FDA Product Code FPL: Incubator, Neonatal Transport
Leading manufacturers include Draeger Medical Systems, Inc., International Biomedical and Cavitron Corp..
25
Total
25
Cleared
95d
Avg days
1978
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Incubator, Neonatal Transport Devices (Product Code FPL)
25 devices
Cleared
Jul 15, 2022
NxtGen Infant Transport Incubator
International Biomedical
General Hospital
123d
Cleared
Sep 10, 2014
GLOBE-TROTTER GT5400
Draeger Medical Systems, Inc.
General Hospital
90d
Cleared
Jun 10, 1994
MODEL TI500 ISOLETTE INFANT INCUBATOR
Air-Shields, Inc.
General Hospital
95d
Cleared
May 09, 1983
TI-1000 TRANSPORT INCUBATOR
Narco Scientific
General Hospital
40d
Cleared
Jul 27, 1978
TRANSPORT INCUBATOR
Cavitron Corp.
General Hospital
45d
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.