510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182859Substantially Equivalent

Babyleo TN500

Drägerwerk AG & Co. KGaA, Lübeck, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182859 is the FDA 510(k) clearance record for Babyleo TN500, a class II device, cleared for Dragerwerk AG & CO Kgaa on under FDA product code FMZ (Incubator, Neonatal). FDA records list 5 510(k) clearances for Dragerwerk AG & CO Kgaa, from to . As of , FDA records show no recalls naming K182859.

Clearance record

Decision date
Received
(134 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Dragerwerk AG & CO Kgaa Moislinger Allee 53 - 55, Lübeck, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMZ

Trailing 12 months
2 clearances under product code FMZ in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260