Cleared Special

EasyMax BT Self-Monitoring Blood Glucose System (K182057) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182057 · Eps Bio Technology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
24d
Days
Class 2
Risk

K182057 is an FDA 510(k) clearance for the EasyMax BT Self-Monitoring Blood Glucose System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on August 24, 2018 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eps Bio Technology Corp. devices

Submission Details

510(k) Number K182057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date August 24, 2018
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 165
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K182057.
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
K181527 · ACON Laboratories, Inc. · Oct 2018
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
Confidence Blood Glucose Monitoring System
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
FORA GTel Blood Glucose Monitoring System
K173505 · Foracare, Inc. · Aug 2018