510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063146Substantially Equivalent

Accu-Chek Linkassist

Disetronic Medical Systems, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063146 is the FDA 510(k) clearance record for ACCU-CHEK LINKASSIST, a class II device, cleared for Disetronic Medical Systems AG on under FDA product code KZH (Introducer, Syringe Needle). FDA records list 29 510(k) clearances for Disetronic Medical Systems AG, from to . As of , FDA records show no recalls naming K063146.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Disetronic Medical Systems AG 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZH

Trailing 12 months

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

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