FDA Product Code MPO: Infant Heel Warmer (chemical Heat Pack)
Leading manufacturers include CooperSurgical, Inc..
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
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.
MPO devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →