Cleared Traditional

K090609 - OKMETER MATCH BLOOD GLUCOSE MONITORING ...

K090609 is an FDA 510(k) clearance for OKMETER MATCH BLOOD GLUCOSE MONITORING ..., manufactured by Ok Biotech Co., Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K090609 · Ok Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
335d
Days
Class 2
Risk

K090609 is an FDA 510(k) clearance for the OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ok Biotech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on February 4, 2010 after a review of 335 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ok Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K090609

510(k) Number K090609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2009
Decision Date February 04, 2010
Days to Decision 335 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 88d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 275
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K090609.
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
K093712 · Taidoc Technology Corporation · Feb 2010
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
K093635 · Taidoc Technology Corporation · Feb 2010
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
K093005 · Taidoc Technology Corporation · Feb 2010
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
K091547 · Nova Biomedical Corp. · Jan 2010
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
K093035 · Taidoc Technology Corporation · Dec 2009
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
K092099 · Taidoc Technology Corporation · Dec 2009