# K092992: A4-XLR8 Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Jun 29, 2010 after 274 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: 5 generations back to K945062 (1995). 8 ancestors in all.
31 later devices descend from it; 8 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)
- K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K113199: Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit (2012), 10 descendants of its own
- K151261: Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large (2015), 9 descendants of its own
- 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
- K140022: Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product (2014), 5 descendants of its own
- K133333: Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit (2014), 4 descendants of its own

## Indications for use
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris. A4-XLR8 Foam Dressing 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 flap and grafts Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K092992
Methodology: https://510kreport.com/methodology