# K945729: Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep Surface

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Feb 27, 1995 after 97 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K970636: Totalcare., Modular Therapy System (MTS) (1997), 1 descendant of its own
- K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2 (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K945729
Methodology: https://510kreport.com/methodology