510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151236Substantially Equivalent

MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

Medtronic, Inc., Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151236 is the FDA 510(k) clearance record for MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal), a class II device, cleared for Medtronic Minimed, Inc. on under FDA product code PJT (Continuous Glucose Monitor Secondary Display). FDA's definition for product code PJT reads: "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...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K151236.

Clearance record

Decision date
Received
(8 days to decision)
Product code
PJT Continuous Glucose Monitor Secondary Display
Regulation
21 CFR 862.1350
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medtronic Minimed, Inc. 18000 Devonshire St., Northridge CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJT

Trailing 12 months

FDA records hold no clearances under product code PJT in the trailing twelve months.

FDA records show no clearances under product code PJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260