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510(k) K221154

Infant Heel WarmerTM; Heel Snuggler® by International Biomedical — Product Code MPO

K221154 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "Infant Heel WarmerTM; Heel Snuggler®". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. International Biomedical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
April 21, 2022
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 International Biomedical

  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (March 10, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)
  • K140707 — LIFEBORNE INFANT RESUSCITATOR (May 28, 2014)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)

Other clearances for product code MPO

  • K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (March 18, 2016)
  • 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