PMA · Approved
Recalled · Class II · 2025Guardian Connect 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 Mar 8, 2018 through premarket approval, which rests on the device’s own clinical evidence after a 730-day review. It has been recalled 3 times.
- Decided
- Mar 8, 2018
- Review
- 730 days
- Class
- Class III
- Product code
- MDS
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160007 has 55 supplements since 2018: 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 |
|---|---|
| 2018 | 11 |
| 2019 | 16 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 3 |
| 2024 | 5 |
| 2025 | 6 |
| 2026 | 4 |
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 |
|---|---|---|---|---|
| May 7, 2025 | Class II | Z-0033-2026 | Process design | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. |
| May 20, 2019 | Class II | Z-2106-2020 | Software design | Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days… |
| Jul 4, 2018 | Class II | Z-1282-2019 | Software design | The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or… |
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. 2018, this device’s year, is highlighted.
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/P160007 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160007: Guardian Connect system.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160007
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026