Invia White Foam NPWT
FDA 510(k) K180415 · Medela AG
510(k) numberK180415
Submission
- Device name
- Invia White Foam NPWT
- Applicant
- Medela AG
Baar Zug, CH - Received
- February 15, 2018
- Decision date
- November 2, 2018
- 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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| 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.
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| K253510 | Freestyle Mini Hands-freeHGX · Traditional | 04/10/2026SE |
| K253149 | Motion InBra (YM-8801) wearable breast pumpHGX · Traditional | 02/13/2026SE |
| K253498 | Pump In Style® Pro+HGX · Special | 01/22/2026SE |
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| K232608 | Duo Hands-free Breast PumpHGX · Special | 04/12/2024SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | 07/07/2023SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/26/2022SE |
| K210759 | Solo, Swing MaxiHGX · Traditional | 08/11/2021SE |
| K200508 | Pump In StyleHGX · Traditional | 06/15/2020SE |
| K191653 | Freestyle FlexHGX · Traditional | 10/17/2019SE |
Questions and answers
When was Invia White Foam NPWT cleared by the FDA?
Invia White Foam NPWT (K180415) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 260 days after the submission was received.
What is the product code of K180415?
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.