# K142385: Whisper Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Wound RX Medical, LLC
- Decided: May 22, 2015 after 268 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090130: Atmos S041 Wound, Atmos, Inc. (2009) Summary page 7.

## Indications for use
The Whisper Pump System™ 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. Whisper Pump System™ is appropriate for use on the following wounds: * Pressure ulcers * Diabetic/neuropathic ulcers * Venous insufficiency ulcers * Traumatic wounds * Post-operative and dehisced surgical wounds * Explored fistulas » Skin flaps and grafts Contraindications The use of the Whisper Pump System™ is contraindicated in the presence of: * Eschar * Untreated osteomyelitis * Malignancy in wound (with the exception of palliative care to enhance quality of life) * Untreated malnutrition » Exposed , arteries, veins or organs * Necrotic tissue * Non-enteric unexposed fistulas » Exposed nerves * Exposed anastomotic sites * Exposed bone or tendons » Exposed vasculature The Whisper Pump System™ 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/K142385
Methodology: https://510kreport.com/methodology