# PZI: Prescription Use Blood Glucose Meter For Near-Patient Testing

- Device class: 2; regulation: 21 CFR 862.1345; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 802 days (middle half 648–843)
- Recalls: 6 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2015: 2
- 2016: 2
- 2017: 1
- 2018: 3
- 2022: 1
- 2024: 3
- 2026: 1

## Most-cited predicates
- K181043: StatStrip Glucose Hospital Meter System (2018), cited by 4
- K132121: Statstrip Glucose Hospital Meter System (2014), cited by 3
- K150461: StatStrip Xpress Glucose Hospital Meter System (2015), cited by 2
- K200788: Assure Titanium Blood Glucose Monitoring System (2022), cited by 1
- K152986: StatStrip Xpress 2 Glucose Hospital Meter System (2016), cited by 1
- K150281: StatStrip Glucose Hospital Meter (2015), cited by 1

Source page: https://510kreport.com/product-code/PZI
Data by year (CSV): https://510kreport.com/product-code/PZI.csv