# K942184: Clinitron at Home Air Fluided Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Ssi Medical Services, Inc.
- Decided: Feb 7, 1995 after 279 days
- Product code: INX (Bed, Air Fluidized)
- Device class: 2
- Regulation: 21 CFR 890.5160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K964223: Clinitron Rite-Hite (1997), 0 descendants of its own

## Recalls of this device
- May 20, 2005 · Not classified · Z-1555-05: Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.
- Jan 14, 2002 · Not classified · Z-0057-04: Power cord overheating

Source page: https://510kreport.com/device/K942184
Methodology: https://510kreport.com/methodology