PMA · Approved
Recalled · Class I · 2023Freestyle Libre Flash Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Approved on Sep 27, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 422-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Sep 27, 2017
- Review
- 422 days
- Class
- Class III
- Product code
- PZE
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160030 has 54 supplements since 2017: 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 |
|---|---|
| 2017 | 7 |
| 2018 | 18 |
| 2019 | 11 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 4 |
| 2023 | 3 |
| 2024 | 1 |
| 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, 2023 | Class I | Z-1273-2023 | Device Design | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All PZE devicesPZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZE
Too few PZE 510(k)s in any year since 2007 to give a median.
Recalls per year · PZE
No recall names PZE since 2007.
Adverse event reports per year · PZE
1,566in 2025
MAUDE reports naming product code PZE, 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 8 | — | 0 | 63 |
| 2018 | 18 | — | 0 | 2,094 |
| 2019 | 11 | — | 0 | 3,231 |
| 2020 | 5 | — | 0 | 7,222 |
| 2021 | 3 | — | 0 | 69,065 |
| 2022 | 4 | — | 0 | 15,542 |
| 2023 | 3 | — | 0 | 10,607 |
| 2024 | 1 | — | 0 | 4,934 |
| 2025 | 1 | — | 0 | 1,566 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/P160030 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160030: Freestyle Libre Flash 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/P160030
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026