Cleared Special

K100704 - ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

K100704 is an FDA 510(k) clearance for ACCU-CHEK FLEXLINK PLUS INFUSION SET, manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 63-day FDA review.

K100704 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
63d
Days
Class 2
Risk

K100704 is an FDA 510(k) clearance for the ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DE.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Indianapolis, US). The FDA issued a Cleared decision on May 14, 2010 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100704

510(k) Number K100704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date May 14, 2010
Days to Decision 63 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 728
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K100704.
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K100704 · ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
Download PDF FDA Summary Disetronic Medical Sy…