Cleared Traditional

K081726 - TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

K081726 is the FDA 510(k) clearance for TYSONBIO LINK HEALTH MANAGEMENT SYSTEM by Tyson Bioresearch, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K081726 · Tyson Bioresearch, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
69d
Days
Class 2
Risk

K081726 is an FDA 510(k) clearance for the TYSONBIO LINK HEALTH MANAGEMENT SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Chun-Nan, Miao-Li County, TW). The FDA issued a Cleared decision on August 26, 2008 after a review of 69 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 Tyson Bioresearch, Inc. devices

Submission Details

510(k) Number K081726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date August 26, 2008
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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