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
K822386Substantially Equivalent

Cotral I W/4.5 L/hr. Ultrafiltrat. Capa

Hospal Medical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822386 is the FDA 510(k) clearance record for COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA, a class II device, cleared for Hospal Medical Corp. on under FDA product code FII (System, Dialysate Delivery, Sealed). FDA records list 55 510(k) clearances for Hospal Medical Corp., from to . As of , FDA records show no recalls naming K822386.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FII System, Dialysate Delivery, Sealed
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hospal Medical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FII

Trailing 12 months

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

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