Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CSA Medical, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
220 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201183 | Vortex Radial Spray Catheter | CSA Medical, Inc. | 2020-12-07 | 220 | 0 |
| K171626 | truFreeze System | CSA Medical, Inc. | 2017-08-30 | 89 | 0 |
| K172041 | truFreeze System | CSA Medical, Inc. | 2017-07-27 | 21 | 0 |
| K171522 | truFreeze Rapid AV Spray Kit | CSA Medical, Inc. | 2017-07-14 | 50 | 0 |
| K163244 | truFreeze System | CSA Medical, Inc. | 2017-05-24 | 187 | 0 |
| K162695 | truFreeze System | CSA Medical, Inc. | 2016-10-25 | 28 | 0 |
| K161557 | truFreeze System | CSA Medical, Inc. | 2016-07-26 | 50 | 0 |
| K152668 | truFreeze System | CSA Medical, Inc. | 2015-10-14 | 27 | 0 |
| K150920 | truFreeze System | CSA Medical, Inc. | 2015-06-17 | 72 | 0 |
| K143625 | truFreeze System | CSA Medical, Inc. | 2015-01-15 | 24 | 1 |
| K133258 | TRUFREEZE SYSTEM | CSA Medical, Inc. | 2014-06-19 | 239 | 1 |
| K113021 | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT | CSA Medical, Inc. | 2012-02-07 | 119 | 0 |
| K072651 | CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM | CSA Medical, Inc. | 2007-12-07 | 79 | 0 |
| K070893 | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 | CSA Medical, Inc. | 2007-05-01 | 32 | 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