Cleared Traditional

K151236 - MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) (FDA 510(k) Clearance)

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

K151236 · Medtronic Minimed, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 2015
Decision
8d
Days
Class 2
Risk

K151236 is an FDA 510(k) clearance for the MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink .... Classified as Continuous Glucose Monitor Secondary Display (product code PJT), Class II - Special Controls.

Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on May 19, 2015 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Minimed, Inc. devices

Submission Details

510(k) Number K151236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date May 19, 2015
Days to Decision 8 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
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJT Continuous Glucose Monitor Secondary Display
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1350
Definition The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring
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.