FDA Product Code MPO: Infant Heel Warmer (chemical Heat Pack)
Leading manufacturers include Baxter Healthcare Corp, Florida Medical Industries, Inc. and Respironics, Inc..
11
Total
11
Cleared
114d
Avg days
1996
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Infant Heel Warmer (chemical Heat Pack) Devices (Product Code MPO)
11 devices
Cleared
Oct 07, 2022
Infant Heel WarmerTM
International Biomedical
Physical Medicine
169d
Cleared
Mar 18, 2016
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
CooperSurgical, Inc.
Physical Medicine
255d
Cleared
May 27, 2015
Rapid Aid Instant Disposable Infant Heel Warmer
Rapid Aid Corp.
Physical Medicine
77d
Cleared
Apr 08, 2011
DENOVO TEDDY GEL INFANT HEEL WARMER
Denovo Products, LLC
Physical Medicine
126d
Cleared
Sep 19, 2006
INFANT HEEL WARMER BY INTCO
Shanghai Intco Medical Supply Co., Ltd.
Physical Medicine
302d
Cleared
Jan 27, 2004
HEEL SNUGGLER, MODEL 99047
Respironics, Inc.
Physical Medicine
15d
Cleared
Feb 10, 1997
RECOVER INFANT HEEL WARMER (5100)
Florida Medical Industries, Inc.
Physical Medicine
90d
Cleared
Jun 06, 1996
BAXTER SODIUM ACETATE INFANT HEEL WARMER
Baxter Healthcare Corp
Physical Medicine
76d
Cleared
Jan 11, 1996
DEROYAL INDUSTRIES INFANT HEEL WARMER
Debusk Knitting Mills, Div. Deroyal Industries
Physical Medicine
90d
About Product Code MPO - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code MPO since 1996, with 11 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.