# K972549: Simpulse

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Nov 18, 1997 after 133 days
- Product code: FNM (Mattress, Air Flotation, Alternating Pressure)
- Device class: 2
- Regulation: 21 CFR 880.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930673 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930673: Premium, Kinetic Concepts, Inc. (1993) Summary page 1.

## Indications for use
The Simpulse mattress is indicated for patients who would benefit from a pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.

Source page: https://510kreport.com/device/K972549
Methodology: https://510kreport.com/methodology