Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply— 510(k) K161128

Name: FDA 510(k) clearance K161128
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Substantially Equivalent

Medela AG

FDA 510(k) clearance K161128 for Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply, Substantially Equivalent on 2016-12-01. Applicant: Medela AG. Device class: 2.

Clearance details

Applicant: Medela AG
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2016-04-21
Decision date: 2016-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

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K261291 — Nisus NPWT Canister 500-mL (CPC-500)2026-05-21

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K191653 — Freestyle Flex2019-10-17
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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K161128

K-number listed on FDA's recall record

Z-2528-2018 — Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.Class II·Terminated·Medela Inc·20180207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161128.

Data sourced from openFDA. This site is unofficial and independent of the FDA.