Cleared Traditional

POGO Automatic Blood Glucose Monitoring System (K162203) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162203 · Intuity Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
244d
Days
Class 2
Risk

K162203 is an FDA 510(k) clearance for the POGO Automatic Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Intuity Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 6, 2017 after a review of 244 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 Intuity Medical, Inc. devices

Submission Details

510(k) Number K162203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date April 06, 2017
Days to Decision 244 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
156d slower than avg
Panel avg: 88d · This submission: 244d
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 174
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K162203.
On Call Express Mobile Blood Glucose Monitoring System
K180196 · ACON Laboratories, Inc. · Mar 2018
iHealth Align Gluco-Monitoring System (BG1)
K170231 · Andon Health Co, Ltd. · Sep 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · Taidoc Technology Corporation · Apr 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
K153561 · Andon Health Co, Ltd. · Feb 2017
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016
Wireless Smart Gluco-Monitoring System
K153278 · Andon Health Co, Ltd. · Aug 2016