Disposable Hyperbaric Oxygen Chamber

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K840817 ↗

FDA Product Code

KPJ

Device Class

Class II

Regulation

21 CFR Part 878.5650

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Disposable Aerosol T

  Class I

  FDA 510(k) K791538 Active Cleared 7 Sep 1979

• Disposable Medication Nebulizer

  Class II

  FDA 510(k) K791536 Active Cleared 7 Sep 1979

• Breathing Circuit Products, Anesthesia

  Class I

  FDA 510(k) K781908 Active Cleared 27 Nov 1978

• Disposable, Manual Pulmonary Resuscitator

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  FDA 510(k) K873286 Active Cleared 26 Oct 1987

• Disposable Mouthpiece

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  FDA 510(k) K791537 Active Cleared 7 Sep 1979

• Inflatable Air Splints

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  FDA 510(k) K853600 Active Cleared 19 Sep 1985

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• What clinical specialties is this disposable hyperbaric oxygen chamber primarily associated with, and how does that relate to its use?

  This chamber is associated with the General and Plastic Surgery specialties, as indicated by its regulatory filing under the SU (Skin and Soft Tissue) Advisory Committee. While it is cleared for hyperbaric oxygen therapy (HBOT), its primary function is not tied to a specific clinical indication beyond delivering oxygen to targeted tissues in a controlled, portable environment. It is designed for localized treatment applications, making it useful in settings where enhanced oxygen delivery to extremities or small areas is beneficial.

• Is this device intended for single-use or repeated use, and what does that mean for its practical application in a clinical setting?

  The device is explicitly labeled as single-use only, meaning it is not designed for reuse after a single treatment session. This ensures sterility and safety for patients, as it eliminates the need for cleaning or reprocessing between uses. Clinicians should treat it as a disposable item, discarding it after one use to maintain compliance with medical device regulations and infection control protocols.

• How is this hyperbaric oxygen chamber supplied, and are there any specific storage requirements mentioned in the documentation?

  The device is supplied as a disposable unit, meaning it comes pre-packaged and ready for immediate use without additional preparation. While the provided data does not specify detailed storage requirements (such as temperature or humidity controls), standard medical device storage practices—like keeping it in a clean, dry environment away from direct sunlight—should be followed. Since it is single-use, proper inventory management is key to ensuring availability when needed.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use in clinical practice?

  This device was cleared through the FDA 510(k) process (K840817), specifically under the Traditional 510(k) pathway, with a Substantially Equivalent (SESE) determination. This means it was compared to a legally marketed predicate device and deemed to have the same intended use and technological characteristics. Clinically, this clearance confirms it meets FDA safety and effectiveness standards for its designated use in hyperbaric oxygen therapy, though its application remains within the scope of topical/extremity oxygen delivery as defined in regulatory nomenclature.