510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K901157Substantially Equivalent

Mp4, Mp4si, It4 Incubators

Mediprema, Sandpoint ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901157 is the FDA 510(k) clearance record for MP4, MP4SI, IT4 INCUBATORS, a class II device, cleared for Mediprema on under FDA product code FMZ (Incubator, Neonatal). FDA records list one 510(k) clearance for Mediprema. As of , FDA records show no recalls naming K901157.

Clearance record

Decision date
Received
(379 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Mediprema Bird Airlodge, Sandpoint ID
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