Cleared Special

K171822 - NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

K171822 is an FDA 510(k) clearance for NuvoMed Wireless Blood Glucose Monitori..., manufactured by Biotest Medical Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 93-day FDA review.

K171822 · Biotest Medical Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
93d
Days
Class 2
Risk

K171822 is an FDA 510(k) clearance for the NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Biotest Medical Corporation (Taichung, TW). The FDA issued a Cleared decision on September 20, 2017 after a review of 93 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 - K171822

510(k) Number K171822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2017
Decision Date September 20, 2017
Days to Decision 93 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
4d slower than avg
Panel avg: 89d · This submission: 93d
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 K171822.
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
K170079 · Tyson Bioresearch, Inc. · Oct 2017
Gold AQ Blood Glucose Monitoring System
K170264 · Changsha Sinocare, Inc. · Oct 2017
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K171941 · Abbott Diabetes Care, Inc. · Sep 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · Andon Health Co, Ltd. · Sep 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · Biotest Medical Corporation · Sep 2017
GLUCOCARD W Blood Glucose Monitoring System
K170064 · Arkray Factory, Inc. · Aug 2017
K171822 · NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
Download PDF FDA Summary Biotest Medical Corpo…