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510(k) K151845

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) by CooperSurgical, Inc. — Product Code MPO

K151845 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)". The FDA issued a decision of Substantially Equivalent on March 18, 2016. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2016
Date Received
July 7, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infant Heel Warmer (Chemical Heat Pack)
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by CooperSurgical, Inc.

  • K243799 — Fetal Pillow (August 29, 2025)
  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K200038 — Endosee System (February 5, 2020)
  • K191020 — G210 InviCell Plus with SignipHy pH monitoring (January 14, 2020)
  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
  • K190639 — Endosee System (May 15, 2019)
  • K182959 — Wallace Dual Lumen Oocyte Recovery System (May 10, 2019)
  • K183020 — Endosee System (January 31, 2019)

Other clearances for product code MPO

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • K150627 — Rapid Aid Instant Disposable Infant Heel Warmer (May 27, 2015)
  • K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER (April 8, 2011)
  • K053254 — INFANT HEEL WARMER BY INTCO (September 19, 2006)
  • K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (May 3, 2004)
  • K040044 — HEEL SNUGGLER, MODEL 99047 (January 27, 2004)
  • K032989 — MEDI-HEAT INFANT HEEL WARMER (October 22, 2003)
  • K964523 — RECOVER INFANT HEEL WARMER (5100) (February 10, 1997)
  • K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER (June 6, 1996)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)

FDA data resources