Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryocath Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
324 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008-06-27 | 74 | 0 |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | Cryocath Technologies, Inc. | 2007-12-28 | 324 | 0 |
| K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICA | Cryocath Technologies, Inc. | 2006-08-24 | 28 | 0 |
| K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROS | Cryocath Technologies, Inc. | 2006-01-13 | 35 | 1 |
| K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AN | Cryocath Technologies, Inc. | 2004-04-29 | 44 | 0 |
| K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 | Cryocath Technologies, Inc. | 2003-04-29 | 90 | 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