Cleared Special

K182047 - Tyson Bio HT100-A Blood Glucose Monitoring System (FDA 510(k) Clearance)

Also includes:
Tyson Bio HT100-C Blood Glucose Monitoring System

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182047 · Tyson Bioresearch, Inc. · Chemistry device
Nov 2018
Decision
121d
Days
Class 2
Risk

K182047 is an FDA 510(k) clearance for the Tyson Bio HT100-A Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Zhunan Township, TW). The FDA issued a Cleared decision on November 29, 2018 after a review of 121 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date November 29, 2018
Days to Decision 121 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 234d · This submission: 121d
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 14
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K182047.
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · ACON Laboratories, Inc. · Oct 2025
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · Bionime Corporation · Nov 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · Bionime Corporation · Jan 2024
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · I-Sens, Inc. · Aug 2023
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · Apex BioTechnology Corp. · Dec 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
K220421 · Apex BioTechnology Corp. · Nov 2022