510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971198Substantially Equivalent

Babytherm 8004 Babytherm 8010

Drager, Inc., Chantilly VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971198 is the FDA 510(k) clearance record for BABYTHERM 8004 BABYTHERM 8010, a class II device, cleared for Drager, Inc. on under FDA product code FMT (Warmer, Infant Radiant). FDA records list 20 510(k) clearances for Drager, Inc., from to . As of , FDA records show one recall naming K971198.

Clearance record

Decision date
Received
(186 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
Drager, Inc. 4101 Pleasent Valley Rd.,, Chantilly VA
510(k) summary
Summary
Third party review
No

Clearances, product code FMT

Trailing 12 months

FDA records hold no clearances under product code FMT in the trailing twelve months.

FDA records show no clearances under product code FMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260