510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FPLClass II

Incubator, Neonatal Transport

21 CFR 880.5410 / General Hospital
FDA source (opens on fda.gov)

FPL is the FDA product code for Incubator, Neonatal Transport, a class II device type, regulated under 21 CFR 880.5410. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FPL
Device name
Incubator, Neonatal Transport
Regulation
21 CFR 880.5410
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
25
Ingested recalls
1

Clearances, product code FPL

By decision year
25 clearances under product code FPL with a decision year between 1978 and 2022, 2011 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FPL by decision year
YearClearances
19781
19792
19831
19851
19861
19891
19932
19941
20001
20021
20032
20062
20081
20114
20131
20141
20171
20221

Applicants with the most clearances

Product code FPL
Applicants holding the most 510(k) clearances under product code FPL
ApplicantClearances
International Biomedical, Ltd.7
Atom Medical Corporation2
Lmt Lammers Medical Technology GmbH2
Advanced Imaging Research dba Sree Medical Systems1
Air-Shields, Inc.1
Airborne Life Support Systems, Inc.1
Cavitron Corp.1
Draeger Medical Systems, Inc.1
Ferno1
Ferno-Washington Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code