# K151261: Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Oct 7, 2015 after 148 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945062 (1995). 10 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113199: Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit, Kevo Medical Supplies (2012) Summary page 4.

## Most influential descendants
- K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (2017), 8 descendants of its own
- K172145: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (2018), 3 descendants of its own
- K182409: Applied Tissue Technologies PWD™ Platform Wound Dressing (2019), 2 descendants of its own
- K191460: PWD Platform Wound Dressing 3” x 5” Oblong (2019), 1 descendant of its own
- K254019: Wound Geni NPWT System (2026), 0 descendants of its own

## Indications for use
The Invia Foam Dressing Kit is intended to be used in conjunction with the Invia Motion and Invia Liberty NPWT Systems to deliver negative pressure wound therapy to the wound. The Invia Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.. Invia Foam Dressing Kit is appropriate for use on the following wounds: - Pressure Ulcers - Diabetic/Neuropathic Ulcers - Venous Insufficiency Ulcers - Traumatic Wounds - Post-operative and Dehisced Surgical Wounds - Skin Flaps and Grafts

Source page: https://510kreport.com/device/K151261
Methodology: https://510kreport.com/methodology