PMA · Approved
Recalled · Class I · 2026Minimed 630G System with Smartguard (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · OZO Automated Insulin Dosing , Threshold Suspend
Approved on Aug 10, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 580-day review. It has a Class I recall. It has been recalled 10 times, including 2 Class I recalls.
- Decided
- Aug 10, 2016
- Review
- 580 days
- Class
- Class III
- Product code
- OZO
- Recalls
- 10 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150001 has 100 supplements since 2016: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2016 | 5 |
| 2017 | 21 |
| 2018 | 27 |
| 2019 | 21 |
| 2020 | 7 |
| 2021 | 5 |
| 2022 | 7 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2026 | Class II | Z-1740-2026 | Device Design | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site… |
| Jan 31, 2025 | Class II | Z-1259-2025 | Device Design | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing.… |
| Jul 31, 2024 | Class I | Z-0001-2025 | Device Design | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the… |
| Sep 20, 2022 | Class II | Z-0193-2023 | Component change control | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used… |
| Jan 27, 2022 | Class II | Z-0855-2022 | Labeling design | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this… |
| Apr 30, 2020 | Class II | Z-0517-2021 | Nonconforming Material/Component | Missing solder battery connection, which could interrupt power of insulin pump. |
| Nov 21, 2019 | Class I | Z-0955-2020 | Device Design | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly… |
| Oct 3, 2018 | Class II | Z-0683-2019 | Software design (manufacturing process) | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how… |
| May 8, 2017 | Class II | Z-2603-2017 | Device Design | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. |
| May 8, 2017 | Class II | Z-2602-2017 | Device Design | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OZO devicesOZO Automated Insulin Dosing , Threshold Suspend: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZO
Too few OZO 510(k)s in any year since 2007 to give a median.
Recalls per year · OZO
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · OZO
3,599in 2025
MAUDE reports naming product code OZO, 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 | 3 | — | 0 | 0 |
| 2014 | 32 | — | 0 | 15,080 |
| 2015 | 35 | — | 0 | 28,763 |
| 2016 | 28 | — | 0 | 21,282 |
| 2017 | 29 | — | 1 | 30,435 |
| 2018 | 53 | — | 1 | 39,960 |
| 2019 | 31 | — | 1 (1) | 82,392 |
| 2020 | 8 | — | 1 | 77,812 |
| 2021 | 7 | — | 0 | 42,577 |
| 2022 | 9 | — | 0 | 54,924 |
| 2023 | 3 | — | 0 | 29,739 |
| 2024 | 2 | — | 1 (1) | 11,814 |
| 2025 | 1 | — | 0 | 3,599 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P150001 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150001: Minimed 630G System with Smartguard (TM).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026