# K920112: Clinitron C-II

- Pathway: 510(k) (Traditional)
- Applicant: Support Systems Intl.
- Decided: Jan 24, 1992 after 14 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.
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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 24, 2009 · Not classified · Z-1903-2009: Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
- May 5, 2003 · Not classified · Z-0990-03: Malfunction of side-rail latching pin coupled with inadequate directions for use.

Source page: https://510kreport.com/device/K920112
Methodology: https://510kreport.com/methodology