FDA Product Code FPL: Incubator, Neonatal Transport
Leading manufacturers include International Biomedical, Ltd., Atom Medical, Inc. and Lmt Lammers Medical Technology GmbH.
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
Mar 03, 2017
SREE MRI Transport Incubator
Advanced Imaging Research Dba Sree Medical Systems
General Hospital
233d
Cleared
Sep 10, 2014
GLOBE-TROTTER GT5400
Draeger Medical Systems, Inc.
General Hospital
90d
Cleared
May 23, 2013
ATOM TRANSCAPSULE V-707
Atom Medical Corporation
General Hospital
154d
Cleared
May 11, 2011
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
International Biomedical, Ltd.
General Hospital
161d
Cleared
May 11, 2011
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
International Biomedical, Ltd.
General Hospital
161d
Cleared
Apr 15, 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
International Biomedical, Ltd.
General Hospital
135d
Cleared
Apr 15, 2011
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
International Biomedical, Ltd.
General Hospital
135d
Cleared
Jun 06, 2008
AVIATOR TRANSPORT INCUBATOR
International Biomedical, Ltd.
General Hospital
18d
Cleared
Aug 29, 2006
V-808 ATOM TRANSCAPSULE
Atom Medical, Inc.
General Hospital
134d
Cleared
Jul 31, 2006
LMT NOMAG IC 3.0
Lmt Lammers Medical Technology GmbH
General Hospital
11d
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
May 29, 1979
REVISED BATTERY CHARGER
Vickers America Medical Corp.
General Hospital
49d
Cleared
Apr 24, 1979
TRANSPORT INCUBATOR
Narco Air-Shields
General Hospital
35d
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.