FDA Product Code MPO: Infant Heel Warmer (chemical Heat Pack)
Leading manufacturers include CooperSurgical, Inc., International Biomedical and Baxter Healthcare Corp.
11
Total
11
Cleared
114d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
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
Jun 06, 1996
BAXTER SODIUM ACETATE INFANT HEEL WARMER
Baxter Healthcare Corp
Physical Medicine
76d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.