K251646 is an FDA 510(k) clearance for the extriCARE? 1000 Negative Pressure Wound Therapy System, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Alleva Medical Devices (Brea, US). The FDA issued a Cleared decision on October 3, 2025, 127 days after receiving the submission on May 29, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K251646 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 2025 |
| Decision Date | October 03, 2025 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OMP — Negative Pressure Wound Therapy Powered Suction Pump |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4780 |
| 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. |