510(k) · Cleared
Recalled · Class II · 2020MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed, Inc. · PJT Continuous Glucose Monitor Secondary Display
Cleared on May 19, 2015 as substantially equivalent to DEN140038 (unknown applicant, ) after an 8-day review. It has been recalled once.
- Decided
- May 19, 2015
- Review
- 8 days
- Class
- Class II
- Product code
- PJT
- Recalls
- 1
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140038 | Continuous Glucose Monitor Secondary DisplaySummary page 4…ewing Product Branch: Office of In Vitro Diagnostics and Radiological Health (OIR) III. PREDICATE DEVICE [907.92(a)(3)] Dexcom Share Direct Secondary Displays, DEN140038 IV. DEVICE DESCRIPTION [807.92(a)(4)] MiniMed® Connect is a secondary display of continuous glucose monitor… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2020 | Class II | Z-0843-2021 | Device Design | 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 surrounding devices or equipment that may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PJT devicesPJT Continuous Glucose Monitor Secondary Display: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PJT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PJT
Too few PJT 510(k)s in any year since 2007 to give a median.
Recalls per year · PJT
No recall names PJT since 2007.
Adverse event reports per year · PJT
3in 2025
MAUDE reports naming product code PJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (175 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151236: MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151236
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026