Cleared Special

POGO Automatic Blood Glucose Monitoring System (K181316) - FDA 510(k) Clearance

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

K181316 · Intuity Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
27d
Days
Class 2
Risk

K181316 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. (Fremont, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 27 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intuity Medical, Inc. devices

Submission Details

510(k) Number K181316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date June 14, 2018
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 173
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K181316.
FORA GTel Blood Glucose Monitoring System
K173505 · Foracare, Inc. · Aug 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · Taidoc Technology Corporation · Jul 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
K173139 · Bionime Corporation · Jun 2018
Dario LC Blood Glucose Monitoring System
K172723 · Labstyle Innovation, Ltd. · Mar 2018
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