Cleared Traditional

K063146 - ACCU-CHEK LINKASSIST

K063146 is an FDA 510(k) clearance for ACCU-CHEK LINKASSIST, manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K063146 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
42d
Days
Class 2
Risk

K063146 is an FDA 510(k) clearance for the ACCU-CHEK LINKASSIST. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Indianapolis, US). The FDA issued a Cleared decision on November 27, 2006 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063146

510(k) Number K063146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date November 27, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZH Introducer, Syringe Needle

All 40
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K063146.
AUTO-SAFETY INJECTOR-2 (ASI-2)
K082587 · Medical House Products Limited · Oct 2008
COMPACT AUTO-SAFETY INJECTOR (CASI)
K073476 · Medical House (Asi) Limited · Mar 2008
DERMOTHERAP GUN
K062339 · Dermoequipos S.R.L. · Feb 2007
DAI-R
K060141 · Shl Medical, USA · Jun 2006
CONFIDOSE IM AUTO-INJECTOR
K060389 · Pharma-Pen, Inc. · Jun 2006
EZ-JECT
K051667 · Indolor, Ltd. · Sep 2005
K063146 · ACCU-CHEK LINKASSIST
Download PDF FDA Summary Disetronic Medical Sy…