FDA product code CBF: Chamber, Hyperbaric
CBF is the FDA product code for chamber, hyperbaric. It is a Class II device, regulated under 21 CFR 868.5470 and reviewed by the Anesthesiology panel. FDA has cleared 69 510(k) submissions under CBF, 2 in the last five years, from 44 different applicants. The average 510(k) review took 207 days (median 154); 266 days on average over the last three years. FDA has posted 3 recalls for CBF devices.
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Hyperbaric |
| Device class | Class II |
| Regulation | 21 CFR 868.5470 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 135 |
| 2019 | 1 | 879 |
| 2023 | 1 | 457 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every CBF clearance
Top CBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sechrist Industries, Inc. | 5 | 2014-05-30 |
| Reimers Systems, Inc. | 5 | 2011-08-19 |
| Environmental Tectonics Corp. | 3 | 2010-08-13 |
| Gulf Coast Hyperbarics, Inc. | 3 | 2009-05-22 |
| Perry Baromedical Corp. | 3 | 2008-06-11 |
39 more applicants have CBF clearances. See the full list in Caduvo.
Most recent CBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240569 | Fink Engineering Pty, Ltd. | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | 2024-11-21 | 266 |
| K220290 | Us Hyperbaric Network | Revitalair 430+ | 2023-05-04 | 457 |
| K171899 | Oxavita Srl | Revitalair 430F | 2019-11-22 | 879 |
| K163109 | Oxyheal Medical Systems, Inc. | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | 2017-03-22 | 135 |
| K152223 | Oxyheal Medical Systems, Inc. | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | 2016-04-29 | 266 |
Recalls for CBF devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-08-08.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4575 — Topical hyperbaric oxygen chamber, disposable
Frequently asked questions
What is FDA product code CBF?
CBF is the FDA product code for chamber, hyperbaric. It is a Class II device, regulated under 21 CFR 868.5470 and reviewed by the Anesthesiology panel.
What device class is CBF?
Class II, regulation 21 CFR 868.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBF?
Across 69 cleared submissions the average was 207 days from receipt to decision (median 154).
Which companies have the most CBF clearances?
Sechrist Industries, Inc. (5); Reimers Systems, Inc. (5); Environmental Tectonics Corp. (3); Gulf Coast Hyperbarics, Inc. (3); Perry Baromedical Corp. (3).
Have CBF devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2014-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code CBF
- Run a recall and safety report across every CBF manufacturer
- Watch product code CBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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