Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surefire Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
127 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018-04-03 | 19 | 0 |
| K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017-05-17 | 8 | 0 |
| K162359 | Surefire Guiding Catheter | Surefire Medical, Inc. | 2016-09-21 | 29 | 0 |
| K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016-03-11 | 2 | 0 |
| K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015-01-12 | 25 | 0 |
| K140034 | SUREFIRE GUIDING CATHETER | Surefire Medical, Inc. | 2014-02-26 | 50 | 0 |
| K122506 | SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS | Surefire Medical, Inc. | 2012-09-17 | 31 | 0 |
| K121677 | SUREFIRE HI-FLOW MICROCATHETER | Surefire Medical, Inc. | 2012-06-14 | 7 | 0 |
| K113737 | SUREFIRE GUIDE SHEATH | Surefire Medical, Inc. | 2012-02-23 | 65 | 0 |
| K110459 | SUREFIRE INFUSION CATHETER SYSTEM | Surefire Medical, Inc. | 2011-06-24 | 127 | 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