PMA · Approved
Recalled · Class II · 2026Minimed 530G System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · OZO Automated Insulin Dosing , Threshold Suspend
Approved on Sep 26, 2013 through premarket approval, which rests on the device’s own clinical evidence after a 478-day review. It has been recalled 2 times.
- Decided
- Sep 26, 2013
- Review
- 478 days
- Class
- Class III
- Product code
- OZO
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P120010 has 135 supplements since 2013: 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 |
|---|---|
| 2013 | 2 |
| 2014 | 32 |
| 2015 | 36 |
| 2016 | 22 |
| 2017 | 8 |
| 2018 | 20 |
| 2019 | 9 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 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.
Planning a device in OZO? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2026 | Class II | Z-1751-2026 | 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… |
| Mar 13, 2014 | Class II | Z-2544-2014 | Device Design | Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount. |
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. 2013, 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/P120010 · printed Nov 6, 2026
Cite this page
510(k) Report. “P120010: Minimed 530G System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P120010
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026