Cleared Traditional

K202534 - MTM301 Blood Glucose and Ketone Monitoring System (FDA 510(k) Clearance)

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

K202534 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
582d
Days
Class 2
Risk

K202534 is an FDA 510(k) clearance for the MTM301 Blood Glucose and Ketone Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 6, 2022 after a review of 582 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Apex BioTechnology Corp. devices

Submission Details

510(k) Number K202534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date April 06, 2022
Days to Decision 582 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
494d slower than avg
Panel avg: 88d · This submission: 582d
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 507
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K202534.
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · ACON Laboratories, Inc. · Oct 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · Guangdong Transtek Medical Electronics Co., Ltd. · Jan 2025
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · Bionime Corporation · Nov 2024
Sejoy Blood Glucose Monitoring System
K240640 · Sejoy Biomedical Co., Ltd. · Oct 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K241787 · Ascensia Diabetes Care U.S., Inc. · Aug 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
K222126 · Vivachek Biotech (Hangzhou) Co., Ltd. · Aug 2024