510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811457Substantially Equivalent

Model Rs-8100

Rinal Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811457 is the FDA 510(k) clearance record for MODEL RS-8100, a class II device, cleared for Rinal Systems, Inc. on under FDA product code KOC (Accessories, Blood Circuit, Hemodialysis). FDA records list one 510(k) clearance for Rinal Systems, Inc. As of , FDA records show no recalls naming K811457.

Clearance record

Decision date
Received
(32 days to decision)
Product code
KOC Accessories, Blood Circuit, Hemodialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rinal Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KOC

Trailing 12 months

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

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