510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924324Substantially Equivalent

K-1 Infant Transport System W/ Integral Air Compre

K-1 Medical Products, Inc., Sant Ee CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924324 is the FDA 510(k) clearance record for K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE, a class II device, cleared for K-1 Medical Products, Inc. on under FDA product code FMZ (Incubator, Neonatal). FDA records list 2 510(k) clearances for K-1 Medical Products, Inc., from to . As of , FDA records show no recalls naming K924324.

Clearance record

Decision date
Received
(442 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
K-1 Medical Products, Inc. 9932 Prospect Ave., Sant Ee CA
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