Cleared Traditional

FORA GTel Blood Glucose Monitoring System (K173505) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173505 · Foracare, Inc. · Chemistry device
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Aug 2018
Decision
269d
Days
Class 2
Risk

K173505 is an FDA 510(k) clearance for the FORA GTel Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Foracare, Inc. (Moorpark, US). The FDA issued a Cleared decision on August 9, 2018 after a review of 269 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 Foracare, Inc. devices

Submission Details

510(k) Number K173505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date August 09, 2018
Days to Decision 269 days
Submission Type Traditional
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
181d slower than avg
Panel avg: 88d · This submission: 269d
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 173
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K173505.
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · Eps Bio Technology Corp. · Aug 2018
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K173658 · Applied Biomedical, LLC · Aug 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
K173638 · Bionime Corporation · Aug 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · Taidoc Technology Corporation · Jul 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
K173139 · Bionime Corporation · Jun 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · Intuity Medical, Inc. · Jun 2018