Cleared Special

K143169 - MyGlucoHealth Wireless System

K143169 is an FDA 510(k) clearance for MyGlucoHealth Wireless System, manufactured by Entra Health Systems. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 430-day FDA review.

K143169 · Entra Health Systems · Chemistry device
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Jan 2016
Decision
430d
Days
Class 2
Risk

K143169 is an FDA 510(k) clearance for the MyGlucoHealth Wireless System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Entra Health Systems (San Diego, US). The FDA issued a Cleared decision on January 8, 2016 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Entra Health Systems devices

FDA 510(k) Submission Details - K143169

510(k) Number K143169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date January 08, 2016
Days to Decision 430 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 88d · This submission: 430d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

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 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K143169.
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