# 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

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: May 9, 2018 after 296 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: 9 generations back to K945062 (1995). 37 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Medela AG (2016) Summary page 8.
- K142626: Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters, Medela AG (2015) Summary page 8.
- K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film, Medela AG (2017) Summary page 8.
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit, Kci USA, Inc. (2012) Summary page 8.

## Most influential descendants
- 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

## Indications for use
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds 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. When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy. 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 – Closed surgical incisions The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds 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. When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy. The Invia Liberty 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 – Closed surgical incisions 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 when used on open wounds 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. When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy. The Invia Foam Dressing Kit with FitPad 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 – Closed surgical incisions 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 when used on open wounds 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. When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy. The Invia Gauze Dressing Kit with FitPad 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 – Closed surgical incisions

Source page: https://510kreport.com/device/K172145
Methodology: https://510kreport.com/methodology