# P050020: Freestyle Navigator Continuous Glucose Monitor

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Mar 12, 2008 after 1,008 days
- Product code: MDS (Sensor, Glucose, Invasive)
- Device class: 3
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 14, 2009 · Not classified · Z-0820-2010: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.

Source page: https://510kreport.com/device/P050020
Methodology: https://510kreport.com/methodology