Cleared Special

K132862 - HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

K132862 is an FDA 510(k) clearance for HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MO..., manufactured by Infopia Co, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 91-day FDA review.

K132862 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
91d
Days
Class 2
Risk

K132862 is an FDA 510(k) clearance for the HEALTHPRO PROFESSIONAL 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. (Anaheim, US). The FDA issued a Cleared decision on December 12, 2013 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K132862

510(k) Number K132862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2013
Decision Date December 12, 2013
Days to Decision 91 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 89d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K132862.
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · ACON Laboratories, Inc. · Dec 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · ACON Laboratories, Inc. · Dec 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · I-Sens, Inc. · Dec 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132966 · Infopia Co, Ltd. · Dec 2013
PRODIGY CHOICE
K122340 · Prodigy Diabetes Care, LLC · Nov 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · General Life Biotechnology Co., Ltd. · Nov 2013
K132862 · HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Infopia Co, Ltd.