Cleared Traditional

K080636 - DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100

K080636 is an FDA 510(k) clearance for DUO-MAX BLOOD PRESSURE & GLUCOSE MONITO..., manufactured by Hubdic Co., Ltd.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K080636 · Hubdic Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
344d
Days
Class 2
Risk

K080636 is an FDA 510(k) clearance for the DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Hubdic Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 344 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 Hubdic Co., Ltd. devices

FDA 510(k) Submission Details - K080636

510(k) Number K080636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2008
Decision Date February 13, 2009
Days to Decision 344 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
256d slower than avg
Panel avg: 88d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 301
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K080636.
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814 · Taidoc Technology Corporation · Nov 2009
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
K090043 · Apex BioTechnology Corp. · Apr 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570 · Taidoc Technology Corporation · Mar 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
K082482 · Taidoc Technology Corporation · Jan 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
K083664 · Taidoc Technology Corporation · Jan 2009
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121 · Eps Bio Technology Corp. · Sep 2008