FDA product code OMP: Negative Pressure Wound Therapy Powered Suction Pump
OMP is the FDA product code for negative pressure wound therapy powered suction pump. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. FDA has cleared 215 510(k) submissions under OMP, 39 in the last five years, from 70 different applicants. The average 510(k) review took 192 days (median 171); 183 days on average over the last three years. FDA has posted 47 recalls for OMP devices, 5 initiated in the last five years.
Definition
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. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Classification
| Field | Value |
|---|---|
| Device name | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class II |
| Regulation | 21 CFR 878.4780 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OMP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 11 | 168 |
| 2018 | 13 | 182 |
| 2019 | 15 | 211 |
| 2020 | 6 | 218 |
| 2021 | 9 | 282 |
| 2022 | 10 | 271 |
| 2023 | 8 | 313 |
| 2024 | 9 | 224 |
| 2025 | 5 | 169 |
| 2026 | 7 | 157 |
Compare with all 510(k) review times · Search every OMP clearance
Top OMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kci USA, Inc. | 26 | 2024-05-23 |
| Genadyne Biotechnologies, Inc. | 14 | 2026-03-12 |
| Smith & Nephew Medical Limited | 14 | 2022-11-22 |
| Smith & Nephew, Inc. | 14 | 2016-09-29 |
| Medela AG | 13 | 2023-07-07 |
65 more applicants have OMP clearances. See the full list in Caduvo.
Most recent OMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261338 | Smith & Nephew Medical, Ltd. | RENASYS DYNAFLOW Kit (66807741) | 2026-09-11 | 141 |
| K253263 | Convatec Limited, Gdc Building | ConvaVAC Negative Pressure Wound Therapy System | 2026-06-24 | 268 |
| K253199 | CG Bio Co., Ltd. | CURASYS 2 (EMDN0003) | 2026-06-23 | 270 |
| K260646 | Smith & Nephew Medical, Ltd. | RENASYS EDGE (66803126) | 2026-05-27 | 89 |
| K261291 | Cork Medical | Nisus NPWT Canister 500-mL (CPC-500) | 2026-05-21 | 31 |
Recalls for OMP devices
47 product recalls in 25 recall events; 5 initiated in the last five years and 8 still open. Most recent: 2025-01-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2024 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OMP?
OMP is the FDA product code for negative pressure wound therapy powered suction pump. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.
What device class is OMP?
Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMP?
Across 215 cleared submissions the average was 192 days from receipt to decision (median 171).
Which companies have the most OMP clearances?
Kci USA, Inc. (26); Genadyne Biotechnologies, Inc. (14); Smith & Nephew Medical Limited (14); Smith & Nephew, Inc. (14); Medela AG (13).
Have OMP devices been recalled?
Yes: 47 product recalls across 25 recall events; the most recent began 2025-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OMP
- Run a recall and safety report across every OMP manufacturer
- Watch product code OMP 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