FDA product code · Clinical chemistry
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
1 FDA decision since 2017. No recall names this code.
A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PZE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in PZE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report