Cleared Traditional

Confidence Blood Glucose Monitoring System (K173658) - FDA 510(k) Clearance

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

K173658 · Applied Biomedical, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
265d
Days
Class 2
Risk

K173658 is an FDA 510(k) clearance for the Confidence Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Applied Biomedical, LLC (Placentia, US). The FDA issued a Cleared decision on August 21, 2018 after a review of 265 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 Applied Biomedical, LLC devices

Submission Details

510(k) Number K173658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2017
Decision Date August 21, 2018
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
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 Consultant

Mdi Consultants, Inc.
Jigar Shah

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 175
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K173658.
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · Osang Healthcare Co. , Ltd. · Sep 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · I-Sens, Inc. · Aug 2018
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · Eps Bio Technology Corp. · 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
FORA GTel Blood Glucose Monitoring System
K173505 · Foracare, Inc. · Aug 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · Taidoc Technology Corporation · Jul 2018