PMA · Approved
Recalled · Class II · 2026Continuous Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · MDS Sensor, Glucose, Invasive
Approved on Jun 15, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 547-day review. It has been recalled 14 times.
- Decided
- Jun 15, 1999
- Review
- 547 days
- Class
- Class III
- Product code
- MDS
- Recalls
- 14
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980022 has 186 supplements since 2000: 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 |
|---|---|
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 21 |
| 2009 | 20 |
| 2010 | 18 |
| 2011 | 14 |
| 2012 | 21 |
| 2013 | 18 |
| 2014 | 21 |
| 2015 | 18 |
| 2016 | 9 |
| 2017 | 2 |
| 2018 | 7 |
| 2019 | 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 MDS? 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-1749-2026 | 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… |
| Feb 13, 2026 | Class II | Z-1750-2026 | 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-1256-2025 | 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.… |
| Jun 27, 2019 | Class II | Z-1592-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1589-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1593-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1594-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1590-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1587-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1588-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jun 27, 2019 | Class II | Z-1591-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Jul 22, 2015 | Class II | Z-2442-2015 | Software design | Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in… |
| Jul 21, 2014 | Class II | Z-2179-2014 | Device Design | Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors. |
| 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. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MDS devicesMDS Sensor, Glucose, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDS
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MDS
Too few MDS 510(k)s in any year since 2007 to give a median.
Recalls per year · MDS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDS
2,803in 2025
MAUDE reports naming product code MDS, 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 | 11 | — | 0 | 14 |
| 2008 | 33 | — | 1 | 20 |
| 2009 | 35 | — | 20 | 127 |
| 2010 | 37 | — | 0 | 4,957 |
| 2011 | 24 | — | 0 | 6,450 |
| 2012 | 31 | — | 0 | 1,821 |
| 2013 | 29 | — | 0 | 683 |
| 2014 | 40 | — | 0 | 36,209 |
| 2015 | 45 | — | 0 | 39,944 |
| 2016 | 52 | — | 0 | 97,212 |
| 2017 | 40 | — | 0 | 48,848 |
| 2018 | 79 | — | 0 | 9,085 |
| 2019 | 47 | — | 1 | 2,127 |
| 2020 | 14 | — | 1 | 935 |
| 2021 | 13 | — | 0 | 590 |
| 2022 | 8 | — | 1 | 10,571 |
| 2023 | 3 | — | 0 | 13,881 |
| 2024 | 4 | — | 0 | 4,138 |
| 2025 | 7 | — | 1 | 2,803 |
| 2026 | 5 | — | 0 | — |
https://510kreport.com/device/P980022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980022: Continuous Glucose Monitoring System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026