510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K124024Substantially Equivalent

Apd Luer-Lock Adapter

Fresensius Medical Care North America, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K124024 is the FDA 510(k) clearance record for APD LUER-LOCK ADAPTER, a class II device, cleared for Fresensius Medical Care North America on under FDA product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable). FDA records list one 510(k) clearance for Fresensius Medical Care North America. As of , FDA records show one recall naming K124024.

Clearance record

Decision date
Received
(265 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
Fresensius Medical Care North America 920 Winter St., Waltham MA
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDJ, 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