510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151845Substantially Equivalent

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

CooperSurgical, Inc., Trumbull CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151845 is the FDA 510(k) clearance record for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418), a class I device, cleared for CooperSurgical, Inc. on under FDA product code MPO (Infant Heel Warmer (Chemical Heat Pack)). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show no recalls naming K151845.

Clearance record

Decision date
Received
(255 days to decision)
Product code
MPO Infant Heel Warmer (Chemical Heat Pack)
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
CooperSurgical, Inc. 95 Corporate Dr., Trumbull CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPO

Trailing 12 months

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

FDA records show no clearances under product code MPO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPO, 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