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

Warmer, Infant Radiant

21 CFR 880.5130 / General Hospital
FDA source (opens on fda.gov)

FMT is the FDA product code for Warmer, Infant Radiant, a class II device type, regulated under 21 CFR 880.5130. As of , FDA records hold 92 510(k) clearances under this code, the most recent dated , and 36 recalls.

Classification record

Product code
FMT
Device name
Warmer, Infant Radiant
Regulation
21 CFR 880.5130
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
92
Ingested recalls
36

Clearances, product code FMT

By decision year
92 clearances under product code FMT with a decision year between 1979 and 2025, 1996 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code FMT by decision year
YearClearances
19792
19801
19811
19821
19832
19844
19855
19863
19876
19887
19891
19911
19923
19932
19946
19954
19969
19979
19981
20002
20011
20022
20031
20061
20072
20091
20101
20111
20124
20131
20181
20202
20211
20221
20231
20251

Applicants with the most clearances

Product code FMT
Applicants holding the most 510(k) clearances under product code FMT
ApplicantClearances
GE Healthcare14
Contour Medical Technology, Inc.6
Air-Shields, Inc.5
Atom Medical Corporation4
Fisher & Paykel Electronics, Ltd.4
Gempco, Inc.4
Hill-Rom Inc.4
DeRoyal Industries, Inc.3
Draeger Medical Systems, Inc.3
Ohio Medical Products3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order