510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771428Substantially Equivalent

Tenckhoff Peritoneal Tubing Adapt.

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

K771428 is the FDA 510(k) clearance record for TENCKHOFF PERITONEAL TUBING ADAPT., a class II device, cleared for Quinton, Inc. on under FDA product code FKY (Connector, Tubing, Dialysate). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K771428.

Clearance record

Decision date
Received
(78 days to decision)
Product code
FKY Connector, Tubing, Dialysate
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Quinton, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKY

Trailing 12 months

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

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