# K113199: Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kevo Medical Supplies
- Decided: Jul 30, 2012 after 273 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: 6 generations back to K945062 (1995). 9 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092992: A4-XLR8 Foam Dressing, Genadyne Biotechnologies, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
Kevo NPWT- acHemo3O Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- cxHemo3O Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. Kevo NPWT- axHemo3O Foam Dressing Kit 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 Flaps and Grafts Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K113199
Methodology: https://510kreport.com/methodology