Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices — Letter to Health Care Providers
Technology context FDA-cleared Class II hyperbaric oxygen therapy devices in clinical use
Finding: FDA is aware of reports of fires with HBOT devices that resulted in serious injuries and deaths, and sets out specific fire-prevention, training, monitoring and maintenance requirements for providers.
Main limitation: Written for health care providers operating FDA-cleared Class II devices; it does not evaluate lower-pressure chambers marketed for general wellness, and the root cause of the reported fires is not known.
Executive summary
This is the single most important document in the library for anyone considering hyperbaric equipment, and it is a safety communication rather than a study.
Issued on 25 August 2025, it reminds health care providers and facilities about the safe use of hyperbaric oxygen therapy devices and the importance of following the manufacturer's instructions for use. The FDA states it is aware of reports of serious injuries and deaths with the use of HBOT devices.
Specifically, the agency reports awareness of recent fires that occurred with HBOT devices and resulted in serious injuries and deaths. The root cause of these events is stated as not known. The FDA notes that while it believes serious adverse events associated with HBOT devices are rare, providers and users should be aware that these events can and do occur.
The recommendations are concrete: follow the manufacturer's instructions for each device; ensure fire prevention and safety measures are followed; be aware of the heightened risk of fire with oxygen at high concentration; ensure proper grounding equipment is used; ensure staff training is provided and maintained; ensure the patient is properly monitored and supervised throughout treatment; follow manufacturer cleaning procedures, maintenance intervals and safety checks; avoid prohibited items including electrical or static devices; and ensure patients wear hyperbaric-compatible clothing such as cotton, noting that wool and synthetic materials may produce more static electricity.
The document also states that HBOT devices are Class II medical devices cleared through the 510(k) process, identifiable by Product Code CBF in the 510(k) database.
Why this research matters
Hyperbaric is the category where careless language causes the most harm, and this document draws the lines the industry frequently blurs.
It confirms the regulatory status precisely - Class II, 510(k) cleared, Product Code CBF - which gives a buyer a way to check any specific chamber rather than accept a claim. And it establishes that the dominant risk is fire in an oxygen-enriched environment, which is an engineering and operational concern rather than a clinical one.
Study design
- Document type
- Letter to health care providers (safety communication)
- Issuing body
- U.S. Food and Drug Administration
- Date issued
- 25 August 2025
- Audience
- Health care providers and facilities
- Device classification stated
- Class II medical devices, cleared through the 510(k) process
- Device identification
- Product Code CBF in the 510(k) database
- Adverse events referenced
- Reports of fires resulting in serious injuries and deaths; root cause not known
- FDA characterisation of frequency
- Serious adverse events believed to be rare
- Referenced standards
- NFPA 99-2024 Health Care Facilities Code; ASME PVHO-1-2023 Safety Standard for Pressure Vessels for Human Occupancy
- Reporting mechanism
- MedWatch voluntary reporting; mandatory Medical Device Reporting for manufacturers and user facilities
- Study design, sample size, outcomes
- Not applicable - this is a regulatory communication, not a study
What the researchers found
The FDA states it is aware of reports of serious injuries and deaths with the use of HBOT devices, and specifically of recent reports of fires that occurred with HBOT devices resulting in serious injuries and deaths. The root cause of these events is not known.
The FDA believes serious adverse events associated with HBOT devices are rare, while stating that such events can and do occur.
Recommendations issued: review and follow manufacturer instructions for each device; ensure fire prevention and safety measures; recognise the heightened fire risk with high-concentration oxygen; ensure proper grounding equipment; ensure staff training is provided and maintained; ensure patients are properly monitored and supervised throughout treatment; follow manufacturer cleaning, maintenance and safety-check schedules; avoid prohibited items including electrical or static devices; and ensure patients wear hyperbaric-compatible clothing such as cotton, noting that wool and synthetic materials may produce more static electricity.
The document describes HBOT as breathing 100% oxygen in a special chamber where air pressure is raised above normal, helping the lungs collect more oxygen.
No numerical incidence rates, effect sizes or statistical measures are reported in this document, and none are reproduced here.
What the results mean
Two things follow. First, hyperbaric equipment is a regulated medical device class with a documented mechanism of serious harm - fire in an oxygen-enriched environment. Second, the mitigations are operational: training, supervision, prohibited materials, clothing, grounding, and maintenance discipline.
Every one of those mitigations assumes an operator who has been trained and a patient who is monitored. That is the context this device class is designed for, and it is the context in which the FDA discusses it.
The statement that root cause is not known is important. It means the agency has identified a pattern of harm without yet identifying what specifically produced it, which is a reason for more caution rather than less.
What this study does not prove
- It does not establish efficacy of hyperbaric oxygen therapy for any indication; it is a safety communication.
- It does not evaluate lower-pressure chambers marketed for general wellness.
- It does not quantify the incidence of fires or adverse events.
- It does not identify the root cause of the reported fires, which the FDA states is not known.
- It does not indicate that any specific chamber is safe or unsafe.
- It does not constitute medical advice for any individual.
Evidence strength
Regulatory guidance / safety communication
A safety communication from the regulator responsible for the device class. It is not research and does not report a study; it reports adverse events known to the agency and issues recommendations.
Its authority comes from the FDA's access to mandatory adverse event reporting under the Medical Device Reporting regulations, which is information no researcher independently holds.
Strengths and limitations
Strengths
- Issued by the regulator with statutory access to mandatory adverse event reporting.
- Specific, actionable recommendations rather than general caution.
- States the regulatory classification and the means of verifying a specific device.
- References applicable consensus standards (NFPA 99-2024 and ASME PVHO-1-2023).
- Recent, at August 2025.
- Candid that root cause is unknown rather than implying the risk is fully characterised.
Limitations
- Not a study; no incidence data, denominators or statistical analysis.
- Written for health care providers rather than consumers.
- Does not address lower-pressure wellness chambers.
- Root cause of the reported fires not established.
- Adverse event reporting systems capture what is reported, which is an incomplete picture by design.
Does this apply to the equipment IMPERVITA sells?
This applies to FDA-cleared Class II hyperbaric oxygen therapy devices. IMPERVITA discusses hyperbaric systems as a specialist category and does not provide medical treatment, diagnose, or recommend hyperbaric use for any condition.
For a buyer, the practical application is verification. Ask whether a specific chamber has been FDA cleared and for what indication, and check it against Product Code CBF in the 510(k) database. 'FDA registered' and 'FDA listed' are administrative filings and are not clearance; 'FDA approved' describes a different and more demanding pathway.
The fire-safety content applies to any environment where oxygen is concentrated, and the recommendations about prohibited items, clothing materials and grounding are the parts a domestic buyer is least likely to have considered.
This document does not address lower-pressure chambers marketed for wellness. That is not an endorsement of them; it is a gap.
Evidence in context
The regulatory framework is set out in federal regulation, which defines and classifies the hyperbaric chamber as a Class II device. That classification is what the 510(k) clearance pathway referenced here operates under.
The FDA has separately maintained that hyperbaric devices are not proven for a range of conditions for which they are nonetheless marketed. This communication concerns the safety of cleared devices used within their instructions rather than the wider marketing question.
The referenced standards - NFPA 99-2024 for health care facilities and ASME PVHO-1-2023 for pressure vessels for human occupancy - are the engineering and facility standards a professional installation would be built to.
Related research
- 21 CFR 868.5470 - Hyperbaric chamber The federal regulation defining and classifying the hyperbaric chamber as a Class II device.
- General wellness: policy for low risk devices - guidance for industry and FDA staff FDA guidance on where a general wellness product ends and a regulated medical device begins.
- Health products compliance guidance FTC standard for substantiating health claims, relevant to how hyperbaric services are advertised.
- NFPA 70 - National Electrical Code The electrical consensus standard applicable to installation of this and other equipment.
Practical buyer relevance
This is the category where the correct first step is a conversation with a physician, not with a retailer, and this document is the reason.
If you are proceeding, the questions to take to a manufacturer are: has this specific chamber been FDA cleared, for what indication, and can I see the documentation; what standards is it built and tested to; what training do you provide and is it required for the warranty to stand; what is the mandatory inspection and maintenance schedule and who is qualified to perform it; and what does the manufacturer say about unsupervised use.
The fire-safety recommendations should also be read as installation requirements. Room ventilation, grounding, prohibited items and clothing materials are not optional refinements, and your local fire authority should be consulted for any installation.
Safety context
This entry is itself a safety document. The FDA is aware of reports of fires with HBOT devices resulting in serious injuries and deaths, with root cause unknown, and describes a heightened risk of fire with oxygen at high concentration.
Anyone considering hyperbaric equipment for any reason should speak to a physician first. Use should follow medical advice, the manufacturer's instructions exactly, and applicable fire safety requirements. IMPERVITA is an equipment retailer and advisor and does not provide medical treatment or diagnosis.
Full source record
- Title
- Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices — Letter to Health Care Providers
- Authors
- U.S. Food and Drug Administration
- Organization
- U.S. Food and Drug Administration
- Publication
- FDA Letters to Health Care Providers
- Year
- 2025
- Volume / issue / pages
- Issued 25 August 2025
- Study type
- Regulator safety communication (letter to health care providers)
- Sample size
- Not applicable - regulatory communication
- Population
- Health care providers and facilities operating HBOT devices
- Topic
- Hyperbaric, regulatory, Safety
- Document type
- Safety guidance
- Technology context
- FDA-cleared Class II hyperbaric oxygen therapy devices in clinical use
- Related equipment context
- Hyperbaric Systems
- Source last verified
- 19 August 2026
References
Information provided by IMPERVITA is for educational and general wellness purposes and is not intended to replace professional medical advice, diagnosis, or treatment.
