FDA product code OKO: Negative Pressure Wound Therapy Non-Powered Suction Apparatus
OKO is the FDA product code for negative pressure wound therapy non-powered suction apparatus. It is a Class II device, regulated under 21 CFR 878.4683 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under OKO, 6 in the last five years, from 4 different applicants. The average 510(k) review took 104 days (median 101); 118 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
Classification
| Field | Value |
|---|---|
| Device name | Negative Pressure Wound Therapy Non-Powered Suction Apparatus |
| Device class | Class II |
| Regulation | 21 CFR 878.4683 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OKO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 139 |
| 2021 | 1 | 28 |
| 2022 | 1 | 146 |
| 2024 | 2 | 54 |
| 2025 | 2 | 30 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every OKO clearance
Top OKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spiracur, Inc. | 8 | 2015-11-19 |
| Guard Medical, Inc. | 7 | 2025-05-15 |
| VacHeal, LLC | 1 | 2026-09-18 |
| Benq Materials Corporation | 1 | 2020-05-04 |
Most recent OKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254160 | VacHeal, LLC | VacHeal Negative Pressure Wound Therapy System | 2026-09-18 | 270 |
| K251156 | Guard Medical, Inc. | NPseal | 2025-05-15 | 30 |
| K250708 | Guard Medical, Inc. | NPseal | 2025-04-08 | 29 |
| K241522 | Guard Medical, Inc. | NPseal (20 and 25) | 2024-08-15 | 78 |
| K240244 | Guard Medical, Inc. | NPseal (Small, Medium, Large) | 2024-02-29 | 30 |
Recalls for OKO devices
openFDA lists no recalls for product code OKO.
Frequently asked questions
What is FDA product code OKO?
OKO is the FDA product code for negative pressure wound therapy non-powered suction apparatus. It is a Class II device, regulated under 21 CFR 878.4683 and reviewed by the General and Plastic Surgery panel.
What device class is OKO?
Class II, regulation 21 CFR 878.4683. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKO?
Across 17 cleared submissions the average was 104 days from receipt to decision (median 101).
Which companies have the most OKO clearances?
Spiracur, Inc. (8); Guard Medical, Inc. (7); VacHeal, LLC (1); Benq Materials Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OKO
- Run a recall and safety report across every OKO manufacturer
- Watch product code OKO 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times