Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C2 Therapeutics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
391 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163684 | C2 CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2018-01-23 | 391 | 0 |
| K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017-01-05 | 252 | 1 |
| K160994 | C2 CryoBalloon Focal Pear Catheter | C2 Therapeutics, Inc. | 2016-05-19 | 41 | 0 |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation S | C2 Therapeutics, Inc. | 2016-04-13 | 239 | 1 |
| K153541 | Coldplay CryoBalloon® Ablation System | C2 Therapeutics, Inc. | 2016-01-07 | 28 | 0 |
| K152140 | Boa Endoscopic Valve | C2 Therapeutics, Inc. | 2015-10-13 | 71 | 0 |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe | C2 Therapeutics, Inc. | 2015-07-07 | 78 | 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