510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913291Substantially Equivalent

Model C386 Isolette(r) Infant Incubator

Air-Shields, Inc., Hatboro PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913291 is the FDA 510(k) clearance record for MODEL C386 ISOLETTE(R) INFANT INCUBATOR, a class II device, cleared for Air-Shields, Inc. on under FDA product code FMZ (Incubator, Neonatal). FDA records list 33 510(k) clearances for Air-Shields, Inc., from to . As of , FDA records show no recalls naming K913291.

Clearance record

Decision date
Received
(112 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Air-Shields, Inc. 330 Jacksonville Rd., Hatboro 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