extriCARE® 1000 Negative Pressure Wound Therapy System
FDA 510(k) K251646 · Alleva Medical Devices
510(k) numberK251646
Submission
- Device name
- extriCARE® 1000 Negative Pressure Wound Therapy System
- Applicant
- Alleva Medical Devices
Brea, CA, US - Received
- May 29, 2025
- Decision date
- October 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)OMP · Traditional | Cork Medical | 06/27/2025SE |
More from Cork Medical
| 510(k) | Device | Decision |
|---|---|---|
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy SystemOMP · Traditional | 02/09/2023SE |
Questions and answers
When was extriCARE® 1000 Negative Pressure Wound Therapy System cleared by the FDA?
extriCARE® 1000 Negative Pressure Wound Therapy System (K251646) received a 510(k) decision of Substantially Equivalent on October 3, 2025, 127 days after the submission was received.
What is the product code of K251646?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.