510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K850496Substantially Equivalent

Transport Incubator 185

Airborne Life Support Systems, Inc., Cleburne TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850496 is the FDA 510(k) clearance record for TRANSPORT INCUBATOR 185, a class II device, cleared for Airborne Life Support Systems, Inc. on under FDA product code FPL (Incubator, Neonatal Transport). FDA records list one 510(k) clearance for Airborne Life Support Systems, Inc. As of , FDA records show no recalls naming K850496.

Clearance record

Decision date
Received
(104 days to decision)
Product code
FPL Incubator, Neonatal Transport
Regulation
21 CFR 880.5410
Device class
Class II
Review panel
General Hospital
Applicant
Airborne Life Support Systems, Inc. 2409 N. Main, Cleburne TX
Third party review
No

Clearances, product code FPL

Trailing 12 months

FDA records hold no clearances under product code FPL in the trailing twelve months.

FDA records show no clearances under product code FPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260