# K090130: Atmos S041 Wound

- Pathway: 510(k) (Traditional)
- Applicant: Atmos, Inc.
- Decided: Apr 2, 2009 after 71 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: 4 generations back to K945062 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061367: Bluesky Vista Wound Vacuum System, Model 100.0500, Blue Sky Medical Group Incorporated (2006) Summary page 1.

## Most influential descendants
- K142385: Whisper Pump System (2015), 0 descendants of its own

## Indications for use
The ATMOS S041 WoundTM is a suction device intended for aspiration and collection of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. ATMOS S041 is appropriate for use on the following wounds: * Pressure ulcers * Diabetic/neuropathic ulcers * Venous insufficiency ulcers * Traumatic wounds * Post-operative and dehisced surgical wounrds * Explored fistulas * Skin flaps and grafts Contraindications The use of the ATMOS S 041 WOUND is contraindicated in the presence of: *Eschar · Untreated osteomyelitis * Malignancy in wound (with exception of palliative care to enhance quality of life) * Untreated malnutrition * Exposed arteries, veins or organs *Necrotic tissue *Non-enteric unexplored fistulas * Exposed nerves * Exposed anastomotic site * Exposed bone or tendons * Exposed vasculature The ATMOS S 041 WOUND is not designed for use with emergency medical services. Not to be used: * In non-medical applications * In presence of combustible or explosive fluids or gases

Source page: https://510kreport.com/device/K090130
Methodology: https://510kreport.com/methodology