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510(k) K961154

BAXTER SODIUM ACETATE INFANT HEEL WARMER by Baxter Healthcare Corp — Product Code MPO

K961154 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER SODIUM ACETATE INFANT HEEL WARMER". The FDA issued a decision of Substantially Equivalent on June 6, 1996. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1996
Date Received
March 22, 1996
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

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  • K190910 — PrisMax System Version 2 (July 25, 2019)
  • K163530 — PrisMax Control Unit (May 3, 2017)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code MPO

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • 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)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)

FDA data resources