# K955243: Bariair

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Oct 23, 1997 after 708 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BariKare Plus: named in the summary without a submission number

## Recalls of this device
- Oct 21, 1998 · Not classified · Z-0414-03: Electrical failure of the bed due to fluid egress into the junction box.

## Indications for use
The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly: • patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side. • patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.

Source page: https://510kreport.com/device/K955243
Methodology: https://510kreport.com/methodology