# K161128: 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

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Dec 1, 2016 after 224 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). 22 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113678: Invia Motion Negative Pressure Wound Therapy System, Medela AG (2012) Summary page 4.
- K141926: Invia Endure Negative Pressure Wound Therapy System, Medela AG (2014) Summary page 4.

## 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
- K254019: Wound Geni NPWT System (2026), 0 descendants of its own
- K223388: Invia® Integrated Dressing (2023), 0 descendants of its own
- K214112: Invia Ease Negative Pressure Wound Therapy (NPWT) System (2022), 0 descendants of its own

## Recalls of this device
- Feb 7, 2018 · Class II · Z-2528-2018: Device may display a battery missing error.

## Indications for use
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. The Invia Motion NPWT system is appropriate for use for the following indications: — Acute or subacute 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/K161128
Methodology: https://510kreport.com/methodology
