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
K840948Substantially Equivalent

Clear Porous Plastic-Hypoallergenic

Gainor Medical, MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840948 is the FDA 510(k) clearance record for CLEAR POROUS PLASTIC-HYPOALLERGENIC, a class II device, cleared for Gainor Medical on under FDA product code GKX (Instrument, Automated Platelet Counting). FDA records list 11 510(k) clearances for Gainor Medical, from to . As of , FDA records show no recalls naming K840948.

Clearance record

Decision date
Received
(39 days to decision)
Product code
GKX Instrument, Automated Platelet Counting
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Gainor Medical
Third party review
No

Clearances, product code GKX

Trailing 12 months

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

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