510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K914134Substantially Equivalent

Incubator 8000 Sc

National Draeger, Inc., Oakdale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914134 is the FDA 510(k) clearance record for INCUBATOR 8000 SC, a class II device, cleared for National Draeger, Inc. on under FDA product code FMZ (Incubator, Neonatal). FDA records list one 510(k) clearance for National Draeger, Inc. As of , FDA records show no recalls naming K914134.

Clearance record

Decision date
Received
(115 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
National Draeger, Inc. 1004 International Dr., Oakdale PA
510(k) summary
Statement
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