# K151236: MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed, Inc.
- Decided: May 19, 2015 after 8 days
- Product code: PJT (Continuous Glucose Monitor Secondary Display)
- Device class: 2
- Regulation: 21 CFR 862.1350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140038: Continuous Glucose Monitor Secondary Display Summary page 4.

## Recalls of this device
- Nov 12, 2020 · Class II · Z-0843-2021: Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surro

## Indications for use
MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring. MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter. The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

Source page: https://510kreport.com/device/K151236
Methodology: https://510kreport.com/methodology