Longterm NPWT Foam Dressing Kit
FDA 510(k) K182458 · Zhejiang Longterm Medical Technology Co., Ltd.
510(k) numberK182458
Submission
- Device name
- Longterm NPWT Foam Dressing Kit
- Applicant
- Zhejiang Longterm Medical Technology Co., Ltd.
Deqing, CN - Received
- September 10, 2018
- Decision date
- May 23, 2019
- 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | 09/10/2026SE |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitOMP · Traditional | 05/31/2022SE |
| K202823 | Innomed NPWT Silicone Foam DressingOMP · Traditional | 12/15/2021SE |
| K192478 | LT Antibacterial Alginate with Silver DressingFRO · Traditional | 06/17/2020SE |
Questions and answers
When was Longterm NPWT Foam Dressing Kit cleared by the FDA?
Longterm NPWT Foam Dressing Kit (K182458) received a 510(k) decision of Substantially Equivalent on May 23, 2019, 255 days after the submission was received.
What is the product code of K182458?
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.