# K080357: Medela Invia Wound Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Jul 24, 2008 after 164 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: 3 generations back to K945062 (1995). 9 ancestors in all.
75 later devices descend from it; 7 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator, Medela AG (2006) Summary page 1.
- K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats, Kinetic Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own
- K111170: PICO (2011), 26 descendants of its own
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own
- K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 (2009), 15 descendants of its own

## Recalls of this device
- Jul 27, 2011 · Not classified · Z-3172-2011: Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 1

## Indications for use
The Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Source page: https://510kreport.com/device/K080357
Methodology: https://510kreport.com/methodology