510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172962Substantially Equivalent

Nurture Rest

Neonatal Loving Kare, Inc., Dubois PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172962 is the FDA 510(k) clearance record for Nurture Rest, a class I device, cleared for Neonatal Loving Kare, Inc. on under FDA product code OUW (Infant Positioner, Rx, Use In Highly Monitored Setting). FDA's definition for product code OUW reads: "Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen...". FDA records list one 510(k) clearance for Neonatal Loving Kare, Inc. As of , FDA records show no recalls naming K172962.

Clearance record

Decision date
Received
(114 days to decision)
Product code
OUW Infant Positioner, Rx, Use In Highly Monitored Setting
Regulation
21 CFR 880.5680
Device class
Class I
Review panel
General Hospital
Applicant
Neonatal Loving Kare, Inc. 1702 Treasure Lake, Dubois PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUW

Trailing 12 months

FDA records hold no clearances under product code OUW in the trailing twelve months.

FDA records show no clearances under product code OUW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260