Cleared Special

K070189 - ACCU-CHEK ULTRAFLEX INFUSION SET

K070189 is an FDA 510(k) clearance for ACCU-CHEK ULTRAFLEX INFUSION SET, manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 30-day FDA review.

K070189 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
30d
Days
Class 2
Risk

K070189 is an FDA 510(k) clearance for the ACCU-CHEK ULTRAFLEX INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Indianapolis, US). The FDA issued a Cleared decision on February 21, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 - K070189

510(k) Number K070189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date February 21, 2007
Days to Decision 30 days
Submission Type Special
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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1017
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K070189.
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K070189 · ACCU-CHEK ULTRAFLEX INFUSION SET
Download PDF FDA Summary Disetronic Medical Sy…