Cleared Traditional

K181070 - iHealth Wireless Smart Gluco-Monitoring...

K181070 is the FDA 510(k) clearance for iHealth Wireless Smart Gluco-Monitoring... by Andon Health Co, Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K181070 · Andon Health Co, Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2019
Decision
284d
Days
Class 2
Risk

K181070 is an FDA 510(k) clearance for the iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 1, 2019 after a review of 284 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K181070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2018
Decision Date February 01, 2019
Days to Decision 284 days
Submission Type Traditional
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
196d slower than avg
Panel avg: 88d · This submission: 284d
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 235
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K181070.
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