Cleared Special

K101196 - ACCU-CHEK ULTRFLEX INFUSION SET

K101196 is the FDA 510(k) clearance for ACCU-CHEK ULTRFLEX INFUSION SET by Roche Diagnostics Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Special 510(k) pathway after a 120-day FDA review.

K101196 · Roche Diagnostics Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
120d
Days
Class 2
Risk

K101196 is an FDA 510(k) clearance for the ACCU-CHEK ULTRFLEX INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 120 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K101196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2010
Decision Date August 27, 2010
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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