Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PZO — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
167 daysmedian FDA review time
359 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253122 | Sim&Size | Sim&Cure | 2025-12-23 | 89 | 0 |
| K250160 | ANKYRAS | Mentice Spain S.L. | 2025-05-06 | 105 | 0 |
| K242124 | Sim&Size | Sim&Cure | 2024-12-14 | 148 | 0 |
| K230006 | Ankyras | Mentice Spain S.L. | 2023-12-28 | 359 | 0 |
| K222664 | Sim&Size | Sim&Cure | 2023-01-27 | 147 | 0 |
| K213838 | AneuGuide | ArteryFlow Technology Co., Ltd. | 2022-06-01 | 174 | 0 |
| K212373 | Sim&Size | Sim&Cure | 2022-01-27 | 181 | 0 |
| K202322 | Sim&Size | Sim&Cure | 2020-12-31 | 136 | 0 |
| K190049 | Sim&Size | Sim&Cure | 2019-09-17 | 250 | 0 |
| K171534 | SurgicalPreview | Endo Vantage, LLC | 2017-11-08 | 167 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda