FDA product code PZI: Prescription Use Blood Glucose Meter For Near-Patient Testing
PZI is the FDA product code for prescription use blood glucose meter for near-patient testing. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 14 510(k) submissions under PZI, 5 in the last five years, from 4 different applicants. The average 510(k) review took 301 days (median 121); 489 days on average over the last three years. FDA has posted 6 recalls for PZI devices, 6 initiated in the last five years.
Definition
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Classification
| Field | Value |
|---|---|
| Device name | Prescription Use Blood Glucose Meter For Near-Patient Testing |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PZI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 25 |
| 2018 | 3 | 86 |
| 2022 | 1 | 788 |
| 2024 | 3 | 656 |
| 2026 | 1 | 322 |
Compare with all 510(k) review times · Search every PZI clearance
Top PZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corporation | 10 | 2024-02-23 |
| Roche Diagnostics | 2 | 2026-06-12 |
| Taidoc Technology Corporation | 1 | 2024-11-19 |
| Arkray, Inc. | 1 | 2022-05-23 |
Most recent PZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252323 | Roche Diagnostics | cobas pulse blood glucose monitoring system | 2026-06-12 | 322 |
| K221349 | Taidoc Technology Corporation | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | 2024-11-19 | 925 |
| K220272 | Roche Diagnostics | cobas pulse blood glucose monitoring system | 2024-04-26 | 816 |
| K232075 | Nova Biomedical Corporation | StatStrip Glucose Hospital Meter System | 2024-02-23 | 226 |
| K200788 | Arkray, Inc. | Assure Titanium Blood Glucose Monitoring System | 2022-05-23 | 788 |
Recalls for PZI devices
6 product recalls in 2 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-07-29.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code PZI?
PZI is the FDA product code for prescription use blood glucose meter for near-patient testing. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is PZI?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZI?
Across 14 cleared submissions the average was 301 days from receipt to decision (median 121).
Which companies have the most PZI clearances?
Nova Biomedical Corporation (10); Roche Diagnostics (2); Taidoc Technology Corporation (1); Arkray, Inc. (1).
Have PZI devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2026-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code PZI
- Run a recall and safety report across every PZI manufacturer
- Watch product code PZI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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