Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ablacon, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230008 | Ablamap® System | Ablacon, Inc. | 2023-06-08 | 156 | 0 |
| K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | 2023-03-17 | 100 | 0 |
| K203084 | Ablamap Software | Ablacon, Inc. | 2021-08-31 | 322 | 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