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
K800864Substantially Equivalent

Sterile Dispos. Plastic Stopcocks W/tube

Custom Medical Devices Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800864 is the FDA 510(k) clearance record for STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE, a class II device, cleared for Custom Medical Devices Intl., Inc. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 3 510(k) clearances for Custom Medical Devices Intl., Inc. As of , FDA records show no recalls naming K800864.

Clearance record

Decision date
Received
(44 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Custom Medical Devices Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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