510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243606Substantially Equivalent

Babyroo TN300

Draeger Medical Systems, Inc., Telford PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243606 is the FDA 510(k) clearance record for Babyroo TN300, a class II device, cleared for Draeger Medical Systems, Inc. on under FDA product code FMT (Warmer, Infant Radiant). FDA records list 48 510(k) clearances for Draeger Medical Systems, Inc., from to . As of , FDA records show no recalls naming K243606.

Clearance record

Decision date
Received
(57 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
Draeger Medical Systems, Inc. 3135 Quarry Rd., Telford PA
510(k) summary
Summary PDF
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