Cleared Traditional

K132618 - ONETOUCH REVEAL

K132618 is the FDA 510(k) clearance for ONETOUCH REVEAL by Lifescan, Inc.. It is a Class 2 General Hospital device (product code MRZ) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K132618 · Lifescan, Inc. · General Hospital
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Dec 2013
Decision
117d
Days
Class 2
Risk

K132618 is an FDA 510(k) clearance for the ONETOUCH REVEAL. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Lifescan, Inc. (Wayne, US). The FDA issued a Cleared decision on December 16, 2013 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifescan, Inc. devices

Submission Details

510(k) Number K132618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date December 16, 2013
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRZ Accessories, 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.