Cleared Traditional

K132618 - ONETOUCH REVEAL

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

K132618 · Lifescan, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K132618

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
Combination Product No
PCCP Authorized No
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.

MRZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K132618.
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K141273 · Welldoc, Inc. · Jul 2014
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K120209 · American I.V. Products, Inc. · Apr 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314 · Welldoc, Inc. · Feb 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K112370 · Welldoc, Inc. · Oct 2011
K132618 · ONETOUCH REVEAL
Download PDF FDA Summary Lifescan, Inc.