FPL · Class II · 21 CFR 880.5410

FDA Product Code FPL: Incubator, Neonatal Transport

25
Total
25
Cleared
95d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Incubator, Neonatal Transport Devices (Product Code FPL)

25 devices
1–24 of 25
No devices found for this product code.

About Product Code FPL - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code FPL since 1978, with 25 receiving FDA clearance (average review time: 95 days).

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