# K970468: KT Air Bed

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Sep 5, 1997 after 210 days
- Product code: FNM (Mattress, Air Flotation, Alternating Pressure)
- Device class: 2
- Regulation: 21 CFR 880.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875321 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875321: Modified Rotation Air Fluidized Bed/the Therapulse, Kinetic Concepts, Inc. (1988) Summary page 1.
- K880340: Modified Air Fluidized Bed, Kinair, Kinetic Concepts, Inc. (1988) Summary page 1.
- K944094: Triadyne, Kinetic Concepts, Inc. (1995) Summary page 1.

## Recalls of this device
- Jun 6, 2003 · Not classified · Z-0583-05: Weld failure causes side rail welds to turn upside down or break off of the bed.

## Indications for use
The KinAir IV, Therapulse II Air Bed bed is indicated to assist in the prevention and treatment of the complications of immobility, especially for patients who would benefit from a pressure relieving surface with the additional optional benefit of pneumatic pulsation.

Source page: https://510kreport.com/device/K970468
Methodology: https://510kreport.com/methodology