Cleared Traditional

K896951 - SATELLITE G BLOOD GLUCOSE MONITORING SY...

K896951 is the FDA 510(k) clearance for SATELLITE G BLOOD GLUCOSE MONITORING SY... by Medisense, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K896951 · Medisense, Inc. · Chemistry device
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Feb 1990
Decision
73d
Days
Class 2
Risk

K896951 is an FDA 510(k) clearance for the SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medisense, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medisense, Inc. devices

Submission Details

510(k) Number K896951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1989
Decision Date February 26, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K896951.
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · Boehringer Mannheim Corp. · Oct 1990
SYNERMED GLUCOSE REAGENT KIT
K903063 · Synermed, Inc. · Sep 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · Heraeus Kulzer, Inc. · Mar 1990
ONE TOUCH II METER
K895911 · Lifescan, Inc. · Nov 1989
COBAS READY GLUCOSE REAGENT
K895526 · Roche Diagnostic Systems, Inc. · Oct 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · Bayer Corp. · Jun 1989