Cleared Traditional

K911596 - VISION BG MONITOR

K911596 is an FDA 510(k) clearance for VISION BG MONITOR, manufactured by British-American Medical, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K911596 · British-American Medical, Inc. · Chemistry device
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May 1991
Decision
36d
Days
Class 2
Risk

K911596 is an FDA 510(k) clearance for the VISION BG MONITOR. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by British-American Medical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 36 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 British-American Medical, Inc. devices

FDA 510(k) Submission Details - K911596

510(k) Number K911596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date May 15, 1991
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K911596.
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
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