510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874650Substantially Equivalent

Peritoneal Dialysis Kit (Acute and Chronic Form)

Quinton, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874650 is the FDA 510(k) clearance record for PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM), a class II device, cleared for Quinton, Inc. on under FDA product code FKO (Catheter, Peritoneal Dialysis, Single Use). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K874650.

Clearance record

Decision date
Received
(26 days to decision)
Product code
FKO Catheter, Peritoneal Dialysis, Single Use
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Quinton, Inc. 2121 Terry Ave., Seattle WA
Third party review
No

Clearances, product code FKO

Trailing 12 months

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

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