Cleared Traditional

K113192 - HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM

K113192 is the FDA 510(k) clearance for HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM by Infopia Co, Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K113192 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
256d
Days
Class 2
Risk

K113192 is an FDA 510(k) clearance for the HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Fullerton, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 256 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 Infopia Co, Ltd. devices

Submission Details

510(k) Number K113192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date July 13, 2012
Days to Decision 256 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
168d slower than avg
Panel avg: 88d · This submission: 256d
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 K113192.
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K120568 · Abbott Diabetes Care, Inc. · Mar 2012