Cleared Traditional

K130696 - CARESENS N LINK BLOOD GLUCOSE MONITORIN...

Also marketed or referenced as:
CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

K130696 is the FDA 510(k) clearance for CARESENS N LINK BLOOD GLUCOSE MONITORIN... by I-Sens, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K130696 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
160d
Days
Class 2
Risk

K130696 is an FDA 510(k) clearance for the CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by I-Sens, Inc. (Seoul, Korea, KR). The FDA issued a Cleared decision on August 21, 2013 after a review of 160 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all I-Sens, Inc. devices

Submission Details

510(k) Number K130696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2013
Decision Date August 21, 2013
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K130696.
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
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ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · ACON Laboratories, Inc. · Dec 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation · Oct 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040 · Taidoc Technology Corporation · May 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · Abbott Laboratories · Apr 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp. · Mar 2013