# K141961: Genadyne Spiro Foam Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Mar 26, 2015 after 251 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.
No later device cites it as a predicate yet.
0 of 10 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 4.

## Indications for use
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 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 materials and tissue debris. Spiro 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

Source page: https://510kreport.com/device/K141961
Methodology: https://510kreport.com/methodology