Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PZX — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
268 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); EC | Edwards Lifesciences | 2026-06-26 | 179 | 0 |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026-05-22 | 252 | 0 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025-01-15 | 30 | 0 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024-07-29 | 214 | 0 |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2023-11-02 | 28 | 0 |
| K232295 | LAA Exclusion System | Syntheon, LLC | 2023-08-30 | 29 | 0 |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | 2022-10-28 | 268 | 0 |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021-03-03 | 29 | 0 |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2019-08-21 | 85 | 0 |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018-06-28 | 24 | 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