FDA product code · General, Plastic Surgery
OMPNegative Pressure Wound Therapy Powered Suction Pump
Product code OMP covers Negative Pressure Wound Therapy Powered Suction Pump, a Class II device regulated under 21 CFR 878.4780. FDA has cleared 214 devices in this code, 9 of them in the last 12 months. Median review time across the 214 most recent decisions is 171 days. openFDA lists 47 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4780
- Review panel
- General, Plastic Surgery
- Clearances
- 214
What is happening in OMP right now?
OMP (Negative Pressure Wound Therapy Powered Suction Pump) has two findings, most consequential first. 2 first-time filers in the last 12 months, Convatec Limited, Gdc Building and Bechtel Medical, Inc (K253263, K254019). The code is crowded, scoring 75 of 100 — 63 companies hold a clearance here and 9 arrived in the last 12 months (OMP:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253263, K254019 |
| Crowding | Context | OMP:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code OMP cover?
OMP is FDA's product code for Negative Pressure Wound Therapy Powered Suction Pump, a Class II device regulated under 21 CFR 878.4780.
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.
Source: openFDA device/classification · record OMP · retrieved
How many devices has FDA cleared in OMP?
FDA has cleared 214 devices under product code OMP since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253263 | ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | |
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical |
How long does FDA review take for OMP?
The median FDA review time for OMP is 171 days, measured across the 214 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in OMP?
openFDA lists 47 recall records against product code OMP. A recall record covers one firm's corrective action and may span many device lots.
Z-1176-2025Open, ClassifiedKCI USA, INC.
Due to increase in complaints related to leak alarms
Z-0507-2025Open, ClassifiedKCI USA, INC.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Z-0516-2025Open, ClassifiedSmith & Nephew Medical, Ltd.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Z-1596-2024Open, ClassifiedSmith & Nephew Medical, Ltd.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Z-1597-2024Open, ClassifiedSmith & Nephew Medical, Ltd.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Showing the 5 most recently initiated of 47. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for OMP?
MAUDE holds 408 adverse-event reports naming product code OMP, 72 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in OMP unusual?
One month sits above OMP's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 9 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 5 | 0–20 | Within expected (0–20) | |
| 6 | 0–17 | Within expected (0–17) | |
| 7 | 0–19 | Within expected (0–19) | |
| 14 | 0–18 | Within expected (0–18) | |
| 31 | 0–20 | Above expected (0–20) | |
| 14 | 0–31 | Within expected (0–31) | |
| 13 | 0–48 | Within expected (0–48) | |
| 6 | 0–34 | Within expected (0–34) | |
| 14 | 0–33 | Within expected (0–33) | |
| 9 | 0–33 | Within expected (0–33) | |
| 11 | 0–28 | Within expected (0–28) | |
| 10 | 0–31 | Within expected (0–31) | |
| 5 | 0–34 | Within expected (0–34) | |
| 8 | 0–27 | Within expected (0–27) | |
| 9 | 0–30 | Within expected (0–30) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in OMP.
Who has entered OMP in the last year?
2 companies filed in OMP for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Convatec Limited, Gdc Building | K253263 | |
| Bechtel Medical, Inc. | K254019 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in OMP?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in OMP?
Across the 214 most recent decisions, these applicants filed most often in OMP.
| Applicant | Recent clearances |
|---|---|
| Kci USA, Inc. | 26 |
| Genadyne Biotechnologies, Inc. | 14 |
| Smith & Nephew Medical Limited | 14 |
| Smith & Nephew, Inc. | 14 |
| Kci USA, Inc. (Kinetic Concepts, Inc.) | 13 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in OMP file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Smith & Nephew Medical, Ltd. | 21 | 3 |
| Genadyne Biotechnologies, Inc. | 16 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch OMP
Get an email the morning anything changes in OMP — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.