Cleared Special

K110435 - EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM

K110435 is an FDA 510(k) clearance for EASYGLUCO PLUS BLOOD GLUCOSE MONITORING..., manufactured by U. S. Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 218-day FDA review.

K110435 · U. S. Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
218d
Days
Class 2
Risk

K110435 is an FDA 510(k) clearance for the EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by U. S. Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on September 21, 2011 after a review of 218 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110435

510(k) Number K110435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2011
Decision Date September 21, 2011
Days to Decision 218 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
129d slower than avg
Panel avg: 89d · This submission: 218d
Pathway characteristics
Modification to existing cleared device.

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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K110435.
HEALTH-E-CONNECT SYSTEM
K102063 · Alr Technologies · Oct 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · Andon Medical Co., Ltd. · Sep 2011
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · I-Sens, Inc. · Sep 2011
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
K100806 · Delbio Incorporation · Sep 2011
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
K102816 · Apex BioTechnology Corp. · Sep 2011
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
K101631 · Taidoc Technology Corporation · Sep 2011
K110435 · EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary U. S. Diagnostics, In…