510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961825Substantially Equivalent

Ultraset/3l Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961825 is the FDA 510(k) clearance record for ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K961825.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 1620 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code KDJ

Trailing 12 months

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

FDA records show no clearances under product code KDJ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260