Extricare
FDA 510(k) K132225 · Devon Medical, Inc.
510(k) numberK132225
Submission
- Device name
- Extricare
- Applicant
- Devon Medical, Inc.
King Of Prussia, PA, US - Received
- July 17, 2013
- Decision date
- May 15, 2014
- 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 |
|---|---|---|
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…OMP · Traditional | 09/19/2014SE |
| K141578 | Devon Cirona 6200 DVTJOW · Traditional | 06/27/2014SE |
| K132252 | Extricare 100CC/ 250CC/ 400CC CanistersOMP · Special | 09/27/2013SE |
| K131464 | Extricare NPWT Foot DressingOMP · Special | 08/13/2013SE |
| K131743 | Cirona DVT Foot GarmentJOW · Traditional | 07/01/2013SE |
| K130571 | Devon Cirona 6100 DVTJOW · Traditional | 04/09/2013SE |
| K123959 | Circuflow 5150JOW · Traditional | 02/28/2013SE |
| K123647 | Circuflow 5208 Sequential Compression DeviceJOW · Traditional | 02/14/2013SE |
| K102582 | Arterioflow Model 7500 Sequential Compression DeviceJOW · Traditional | 10/07/2010SE |
| K101523 | Circuflow 5200 Sequential Compression DeviceJOW · Traditional | 06/17/2010SE |
Questions and answers
When was Extricare cleared by the FDA?
Extricare (K132225) received a 510(k) decision of Substantially Equivalent on May 15, 2014, 302 days after the submission was received.
What is the product code of K132225?
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.