510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K945567Substantially Equivalent

Qc Cap

Medionics International, Inc., Markham, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945567 is the FDA 510(k) clearance record for QC CAP, a class II device, cleared for Medionics International, Inc. on under FDA product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable). FDA records list 10 510(k) clearances for Medionics International, Inc., from to . As of , FDA records show no recalls naming K945567.

Clearance record

Decision date
Received
(133 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
Medionics International, Inc. 114 Anderson Ave., Markham, Ontario, CA
510(k) summary
Statement
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