MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)— 510(k) K151236

Name: FDA 510(k) clearance K151236
Creator: U.S. Food and Drug Administration
Published: 2015-05-19

Substantially Equivalent

Medtronic Minimed, Inc.

FDA 510(k) clearance K151236 for MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal), Substantially Equivalent on 2015-05-19. Applicant: Medtronic Minimed, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Minimed, Inc.
Product code: Code PJT
Device class: Class 2
Regulation: 21 CFR 862.1350
Advisory panel: Clinical Chemistry
Date received: 2015-05-11
Decision date: 2015-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K151236

K-number listed on FDA's recall record

Z-0843-2021 — CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000Class II·Ongoing·Medtronic Inc.·20201112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151236.

Data sourced from openFDA. This site is unofficial and independent of the FDA.