Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circa Scientific, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
297 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW | Circa Scientific, Inc. | 2025-05-01 | 30 | 0 |
| K243954 | PeriCross™ Epicardial Access Kit | Circa Scientific, Inc. | 2025-04-24 | 122 | 0 |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | 2024-11-26 | 57 | 0 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW | Circa Scientific, Inc. | 2024-09-26 | 132 | 0 |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); C | Circa Scientific, Inc. | 2024-01-31 | 29 | 0 |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperatur | Circa Scientific, Inc. | 2023-05-25 | 297 | 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