# K972176: Home Care Bead Bed

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Jan 16, 1998 after 221 days
- Product code: INX (Bed, Air Fluidized)
- Device class: 2
- Regulation: 21 CFR 890.5160
- 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 K881917 (1988). 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)
- K881917: Fluidair, Kinetic Concepts, Inc. (1988) Summary page 1.

## Indications for use
The Home Care Bead Bed is indicated for patients who would benefit from advanced pressure relief and a dry patient environment. Particular classes of such patients include (among others), victims of the following: Pressure Ulcers - especially draining wounds Skin Flaps and Grafts Bums Acute Exfoliative Dermatitis Oncology: Aids in pain relief Reduces risk of Pathological Fractures

Source page: https://510kreport.com/device/K972176
Methodology: https://510kreport.com/methodology