# K172962: Nurture Rest

- Pathway: 510(k) (Traditional)
- Applicant: Neonatal Loving Kare, Inc.
- Decided: Jan 18, 2018 after 114 days
- Product code: OUW (Infant Positioner, Rx, Use In Highly Monitored Setting)
- Device class: 1
- Regulation: 21 CFR 880.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905629 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090284: Res-Q Infant Wedge and Sling, Cr Enterprises, LLC (2009) Summary page 4.

## Indications for use
The Nurture Rest (including models 100-1-O and 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.

Source page: https://510kreport.com/device/K172962
Methodology: https://510kreport.com/methodology