PMA · Approved
Recalled · 2009Freestyle Navigator Continuous Glucose Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MDS Sensor, Glucose, Invasive
Approved on Mar 12, 2008 through premarket approval, which rests on the device’s own clinical evidence after a 1,008-day review. It has been recalled 21 times.
- Decided
- Mar 12, 2008
- Review
- 1,008 days
- Class
- Class III
- Product code
- MDS
- Recalls
- 21
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050020 has 30 supplements since 2008: 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 |
|---|---|
| 2008 | 7 |
| 2009 | 10 |
| 2010 | 9 |
| 2011 | 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 |
|---|---|---|---|---|
| Apr 14, 2009 | Not classified | Z-0820-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-0821-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1451-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1449-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1446-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1447-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1461-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1452-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1458-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1453-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1460-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1459-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1457-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1445-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1456-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1448-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1450-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1455-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1444-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Apr 14, 2009 | Not classified | Z-1454-2010 | Process control | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. |
| Nov 1, 2008 | Not classified | Z-1196-2009 | Packaging process control | The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. |
The 5 latest of 21 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. 2008, 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/P050020 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050020: Freestyle Navigator Continuous Glucose Monitor.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050020
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026