510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843781Substantially Equivalent

Kinair, Low Air Loss Bed

KCI USA, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843781 is the FDA 510(k) clearance record for KINAIR, LOW AIR LOSS BED, a class II device, cleared for Kinetic Concepts, Inc. on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list 76 510(k) clearances for KCI USA, INC., from to . As of , FDA records show no recalls naming K843781.

Clearance record

Decision date
Received
(124 days to decision)
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Applicant
Kinetic Concepts, Inc. 3417 Steen Dr., San Antonio TX
Third party review
No

Clearances, product code FNL

Trailing 12 months

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

FDA records show no clearances under product code FNL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNL, 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