IMD · Class I · 21 CFR 890.5710

FDA Product Code IMD: Pack, Hot Or Cold, Disposable

82
Total
82
Cleared
75d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Pack, Hot Or Cold, Disposable Devices (Product Code IMD)

82 devices
1–24 of 82
No devices found for this product code.

About Product Code IMD - Regulatory Context

510(k) Submission Activity

82 total 510(k) submissions under product code IMD since 1976, with 82 receiving FDA clearance (average review time: 75 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.