Cleared Special

K121133 - CARESENS N VOICE BLOOD GLUCOSE MONITORI...

K121133 is the FDA 510(k) clearance for CARESENS N VOICE BLOOD GLUCOSE MONITORI... by I-Sens, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 88-day FDA review.

K121133 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
88d
Days
Class 2
Risk

K121133 is an FDA 510(k) clearance for the CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on July 10, 2012 after a review of 88 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 I-Sens, Inc. devices

Submission Details

510(k) Number K121133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date July 10, 2012
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K121133.
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · ACON Laboratories, Inc. · Dec 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · Roche Diagnostics · Oct 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · Taidoc Technology Corporation · Aug 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649 · Apex BioTechnology Corp. · Jul 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K110074 · Health & Life Co., Ltd. · May 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · Abbott Diabetes Care, Inc. · Mar 2012