Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film— 510(k) K170088

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

2017-01-10

Decision date

2017-04-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Baar, CH

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• K251377 — Magic InBra2025-09-18
• K223388 — Invia® Integrated Dressing2023-07-07
• K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System2022-07-26
• K191653 — Freestyle Flex2019-10-17
• K182191 — Invia Abdominal Dressing Kit2019-02-01

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 →

• Z-0773-2020 — Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).Class II·Terminated·Medela Inc·20191202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170088.