FDA product code KPJ: Chamber, Oxygen, Topical, Extremity
KPJ is the FDA product code for chamber, oxygen, topical, extremity. It is a Class II device, regulated under 21 CFR 878.5650 and reviewed by the General and Plastic Surgery panel. FDA has cleared 23 510(k) submissions under KPJ, 2 in the last five years, from 19 different applicants. The average 510(k) review took 199 days (median 162); 47 days on average over the last three years. FDA has posted 2 recalls for KPJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Oxygen, Topical, Extremity |
| Device class | Class II |
| Regulation | 21 CFR 878.5650 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for KPJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 266 |
| 2023 | 1 | 624 |
| 2025 | 1 | 47 |
Compare with all 510(k) review times · Search every KPJ clearance
Top KPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stephenson Industries, Inc. | 3 | 1997-07-28 |
| Vaporox, Inc. | 2 | 2025-03-10 |
| Hospitak, Inc. | 2 | 1984-04-25 |
| Neogenix, LLC Dba Ogenix | 1 | 2019-12-13 |
| Inotec Amd , Ltd. | 1 | 2012-07-03 |
14 more applicants have KPJ clearances. See the full list in Caduvo.
Most recent KPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250188 | Vaporox, Inc. | Wound Treatment System (VHT-200) | 2025-03-10 | 47 |
| K212121 | Vaporox, Inc. | VHT-200 Wound Treatment System | 2023-03-23 | 624 |
| K190742 | Neogenix, LLC Dba Ogenix | EPIFLO-28 | 2019-12-13 | 266 |
| K112634 | Inotec Amd , Ltd. | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | 2012-07-03 | 298 |
| K120764 | Neogenix, LLC | EPIFLO(R) | 2012-04-27 | 45 |
Recalls for KPJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-04-16.
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 KPJ?
KPJ is the FDA product code for chamber, oxygen, topical, extremity. It is a Class II device, regulated under 21 CFR 878.5650 and reviewed by the General and Plastic Surgery panel.
What device class is KPJ?
Class II, regulation 21 CFR 878.5650. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPJ?
Across 23 cleared submissions the average was 199 days from receipt to decision (median 162).
Which companies have the most KPJ clearances?
Stephenson Industries, Inc. (3); Vaporox, Inc. (2); Hospitak, Inc. (2); Neogenix, LLC Dba Ogenix (1); Inotec Amd , Ltd. (1).
Have KPJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KPJ
- Run a recall and safety report across every KPJ manufacturer
- Watch product code KPJ 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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