Data / Medical devices / Negative Pressure Wound Therapy Powered Suction Pump
Negative Pressure Wound Therapy Powered Suction Pump (OMP): 68 FDA-registered makers in 19 countries
68 establishments in 19 countries are registered with the FDA to make Negative Pressure Wound Therapy Powered Suction Pump (product code OMP, Class 2, 21 CFR 878.4780). 39 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 217 510(k) clearances under this code, the latest on October 23, 2026, and lists 25 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OMP
- Device class
- 2
- Regulation
- 878.4780
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 27 |
| United Kingdom | 7 |
| China | 7 |
| Mexico | 5 |
| Ireland | 3 |
| Germany | 3 |
| Taiwan | 2 |
| Sweden | 2 |
| Costa Rica | 2 |
| Switzerland | 1 |
| Bulgaria | 1 |
| South Korea | 1 |
| Israel | 1 |
| Belgium | 1 |
| Netherlands | 1 |
| Finland | 1 |
| Dominican Republic | 1 |
| Malaysia | 1 |
| Turkey | 1 |
Makers of Negative Pressure Wound Therapy Powered Suction Pump
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kci Usa, Inc. | San Antonio, TX, United States | Complaint file establishment, Specification developer | 22 | May 23, 2024 | 0 | 1 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Manufacturer | 22 | May 23, 2024 | 0 | 6 | 0 | api.fda.gov |
| KCI Manufacturing | Athlone - Co. Westmeath, Ireland | Manufacturer | 19 | May 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Specification developer | 14 | September 11, 2026 | 0 | 2 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Hicksville, NY, United States | Manufacturer, Specification developer | 13 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Bohemia, NY, United States | Manufacturer | 12 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medela AG | BAAR Zug, Switzerland | Complaint file establishment, Manufacturer | 10 | July 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Mystic, CT, United States | Repackager or relabeler, Specification developer | 9 | December 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Devon Medical Products (jiangsu) Ltd | Nantong Jiangsu, China | Manufacturer | 7 | June 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Alleva Medical (D.G.) Ltd | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 6 | March 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Alleva Medical Devices | Pomona, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 6 | March 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cork Medical, LLC | Indianapolis, IN, United States | Manufacturer | 5 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 5 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Carilex Medical, Inc. | Guishan District Taoyuan, Taiwan | Exporter to the US, Foreign private label distributor, Manufacturer | 5 | April 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 5 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Talley Group Ltd. | ROMSEY, HANTS. Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 4 | February 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Clear Choice Therapeutics, Inc. | Raleigh, NC, United States | Specification developer | 3 | February 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| KCI NORTH IX (Technical Services Center) | San Antonio, TX, United States | Manufacturer | 3 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| New Horizon Medical Solutions | Las Vegas, NV, United States | Specification developer | 3 | September 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Pensar Medical | Houston, TX, United States | Specification developer | 3 | October 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| Simex Medizintechnik GMBH | Deisslingen Baden-Wurttemberg, Germany | Manufacturer, Specification developer | 3 | January 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Longterm Medical Technology Co., LTD | Huzhou City Zhejiang, China | Manufacturer | 3 | May 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 2 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 2 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Saint Jones Management LP Eood | Sofia Sofia-Grad, Bulgaria | Remanufacturer, Repackager or relabeler | 2 | October 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Manufacturer | 2 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Aoti Ltd. | GALWAY Galway(County), Ireland | Complaint file establishment, Manufacturer | 1 | June 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| ARGENTUM MEDICAL, LLC dba Bravida Medical | Geneva, IL, United States | Contract manufacturer, Manufacturer | 1 | September 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bechtel Medical Inc | Phoenixville, PA, United States | Complaint file establishment, Manufacturer | 1 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | November 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 1 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ivt Medical Ltd. | Raanana Central, Israel | Manufacturer | 1 | September 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Kci Polymedics BV | PEER Limburg, Belgium | Manufacturer | 1 | October 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Lightstone Medical Products (ningbo) Co Ltd | Ningbo Zhejiang, China | Specification developer | 1 | December 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Med Way Inc. | Buford, GA, United States | Manufacturer | 1 | August 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | June 8, 2006 | 0 | 2 | 0 | api.fda.gov |
| Meditop BV | Montfoort Utrecht, Netherlands | Contract manufacturer, Manufacturer | 1 | October 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care AB | Molndal Vastra Gotaland, Sweden | Specification developer | 1 | July 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care Oy | Mikkeli Etela-Savo, Finland | Manufacturer | 1 | July 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Asskea GMBH | Gebesee Thuringia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Averto Medical | Redwood City, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrocare Corporation | Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boyd Corporation | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brightwake Ltd | Kirkby-in-Ashfield Nottinghamshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadent Technologies, Inc. | Temecula, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cenefom Corp | Zhunan Township Miaoli, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Cientifica De Latinoamerica S.R.L. | La Aurora, Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront Medical Technology (jiangsu) Co.,ltd | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products | CASTLEREA Roscommon, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Medical Limited | Littlehampton West Sussex, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Note Torsby AB | Torsby Varmland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. (UK) Limited | Kelso Scottish Borders, The, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Iso Medical Products Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Systagenix Wound Management Manufacturing Limited | North Yorkshire, United Kingdom | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TMT Manufacturing Sdn Bhd | Butterworth Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Virtual Trutrends Tek.bil.ilt.sis.san.dan.egt.ve Tic.ltd.sti. | ankara, Turkey | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venusa de Mexico S. de R.L de C.V | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.