510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103549Substantially Equivalent

Denovo Teddy Gel Infant Heel Warmer

Denovo Products, LLC, Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K103549 is the FDA 510(k) clearance record for DENOVO TEDDY GEL INFANT HEEL WARMER, a class I device, cleared for Denovo Products, LLC on under FDA product code MPO (Infant Heel Warmer (Chemical Heat Pack)). FDA records list one 510(k) clearance for Denovo Products, LLC. As of , FDA records show no recalls naming K103549.

Clearance record

Decision date
Received
(126 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
Denovo Products, LLC 17051 Alico Commerce Ct., Fort Myers FL
510(k) summary
Statement
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