Surefire Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Surefire Medical, Inc.” (first 2011, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 27 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 31 |
| 2013 | 0 | — |
| 2014 | 1 | 50 |
| 2015 | 1 | 25 |
| 2016 | 2 | 16 |
| 2017 | 1 | 8 |
| 2018 | 1 | 19 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surefire Medical, Inc. took a median 14 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 7 | 7 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Surefire Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180677 | Surefire Spark Infusion System | DQO | 2018-04-03 | 19 |
| K171355 | Surefire Precision Infusion System | DQO | 2017-05-17 | 8 |
| K162359 | Surefire Guiding Catheter | DQY | 2016-09-21 | 29 |
| K160662 | Surefire Infusion System | DQO | 2016-03-11 | 2 |
| K143588 | Surefire Infusion System 021 | DQO | 2015-01-12 | 25 |
| K140034 | SUREFIRE GUIDING CATHETER | DQY | 2014-02-26 | 50 |
| K122506 | SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS | DQX | 2012-09-17 | 31 |
| K121677 | SUREFIRE HI-FLOW MICROCATHETER | DQO | 2012-06-14 | 7 |
| K113737 | SUREFIRE GUIDE SHEATH | DQO | 2012-02-23 | 65 |
| K110459 | SUREFIRE INFUSION CATHETER SYSTEM | DQO | 2011-06-24 | 127 |
Recalls
openFDA lists no recalls under a recalling firm named Surefire Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Surefire Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Surefire Medical, Inc.” (first 2011, latest 2018), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surefire Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surefire Medical, Inc. is 27 days.
Which FDA product codes appear under Surefire Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 7); DQY (Catheter, Percutaneous, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 10 Surefire Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Surefire Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.