FDA product code PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices
PZO is the FDA product code for software for visualization of vascular anatomy and intravascular devices. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Cardiovascular panel. FDA has cleared 10 510(k) submissions under PZO, 7 in the last five years, from 4 different applicants. The average 510(k) review took 176 days (median 158); 122 days on average over the last three years.
Definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Classification
| Field | Value |
|---|---|
| Device name | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for PZO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 167 |
| 2019 | 1 | 250 |
| 2020 | 1 | 136 |
| 2022 | 2 | 178 |
| 2023 | 2 | 253 |
| 2024 | 1 | 148 |
| 2025 | 2 | 97 |
Compare with all 510(k) review times · Search every PZO clearance
Top PZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sim&Cure | 6 | 2025-12-23 |
| Mentice Spain S.L. | 2 | 2025-05-06 |
| ArteryFlow Technology Co., Ltd. | 1 | 2022-06-01 |
| Endo Vantage, LLC | 1 | 2017-11-08 |
Most recent PZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253122 | Sim&Cure | Sim&Size | 2025-12-23 | 89 |
| K250160 | Mentice Spain S.L. | ANKYRAS | 2025-05-06 | 105 |
| K242124 | Sim&Cure | Sim&Size | 2024-12-14 | 148 |
| K230006 | Mentice Spain S.L. | Ankyras | 2023-12-28 | 359 |
| K222664 | Sim&Cure | Sim&Size | 2023-01-27 | 147 |
Recalls for PZO devices
openFDA lists no recalls for product code PZO.
Frequently asked questions
What is FDA product code PZO?
PZO is the FDA product code for software for visualization of vascular anatomy and intravascular devices. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Cardiovascular panel.
What device class is PZO?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZO?
Across 10 cleared submissions the average was 176 days from receipt to decision (median 158).
Which companies have the most PZO clearances?
Sim&Cure (6); Mentice Spain S.L. (2); ArteryFlow Technology Co., Ltd. (1); Endo Vantage, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZO
- Run a recall and safety report across every PZO manufacturer
- Watch product code PZO 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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