# K964223: Clinitron Rite-Hite

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: May 28, 1997 after 217 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
Longest line of descent: 1 generation back to K942184 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943385: Clinitron Elexis, Ssi Medical Services, Inc. (1995) Summary page 1.
- K942184: Clinitron at Home Air Fluided Therapy, Ssi Medical Services, Inc. (1995) Summary page 1.

## Recalls of this device
- Feb 3, 2012 · Not classified · Z-1131-2012: The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 tha
- Feb 3, 2012 · Not classified · Z-1132-2012: The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 tha

## Indications for use
The CLINITRON® RITESHITE"™ Air Fluidized Therapy 1s intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome, purpura fulminans, aid in infection control, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time. The bed will permit easy positioning and egress, thereby enhancing the independence of residents.

Source page: https://510kreport.com/device/K964223
Methodology: https://510kreport.com/methodology