PICO Single Use Negative Pressure Wound Therapy System
FDA 510(k) K151436 · Smith & Nephew Medical, Ltd.
Submission
- Device name
- PICO Single Use Negative Pressure Wound Therapy System
- Applicant
- Smith & Nephew Medical, Ltd.
Hull, GB - Received
- May 28, 2015
- Decision date
- January 28, 2016
- 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 |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | 09/11/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | 05/27/2026SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | 09/11/2025SE |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…OMP · Traditional | 02/18/2025SE |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE GloveKGN · Traditional | 12/17/2024SE |
| K231939 | Renasys EdgeOMP · Traditional | 05/24/2024SE |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam…FRO · Traditional | 08/18/2023SE |
| K220964 | VERSAJET Hydrosurgery System (III)FQH · Traditional | 05/16/2023SE |
| K223041 | Renasys Edge (66803126)OMP · Traditional | 11/22/2022SE |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingOMP · Traditional | 01/14/2022SE |
Questions and answers
When was PICO Single Use Negative Pressure Wound Therapy System cleared by the FDA?
PICO Single Use Negative Pressure Wound Therapy System (K151436) received a 510(k) decision of Substantially Equivalent on January 28, 2016, 245 days after the submission was received.
What is the product code of K151436?
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.