# K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Apr 6, 2017 after 86 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945062 (1995). 31 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151261: Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large, Medela AG (2015) Summary page 6.
- K141847: Avance Foam Dressing Kits, Molnlycke Health Care Us, LLC (2015) Summary page 6.
- K113678: Invia Motion Negative Pressure Wound Therapy System, Medela AG (2012) Summary page 6.
- K123507: Kci NPWT Gauze Dressing, Kci USA, Inc. (2013) Summary page 6.

## Most influential descendants
- 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
- K223388: Invia® Integrated Dressing (2023), 0 descendants of its own

## Recalls of this device
- Dec 2, 2019 · Class II · Z-0773-2020: Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

## Indications for use
The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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. The Invia Foam Dressing Kit with FitPad is appropriate for use on the following wounds: – Acute or sub-acute wounds – Chronic wounds – Dehisced wounds – Pressure ulcers – Diabetic/neuropathic ulcers – Venous insufficiency ulcers – Traumatic wounds – Partial thickness burns – Flaps and grafts The Invia Gauze Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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. Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds: – Acute or sub-acute wounds – Chronic wounds – Dehisced wounds – Pressure ulcers – Diabetic/neuropathic ulcers – Venous insufficiency ulcers – Traumatic wounds – Partial thickness burns – Flaps and Grafts

Source page: https://510kreport.com/device/K170088
Methodology: https://510kreport.com/methodology