Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac via Therapy Unit
K120033 is the FDA 510(k) clearance record for ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT, a class II device, cleared for Kci USA, Inc. on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "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...". FDA records list 76 510(k) clearances for Kci USA, Inc., from to . As of , FDA records show no recalls naming K120033.
Clearance record
- Decision date
- Received
- (148 days to decision)
- Product code
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Kci USA, Inc. 6203 Farinon Dr., San Antonio TX
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OMP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 3 |
| June 2026 | 2 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
