Surefire Medical, Inc.
Surefire Medical, Inc. has 0 FDA recalls, 2 inspections, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 1, 2018 · VAI
- Latest 510(k)
- Apr 3, 2018
Reviewing Surefire Medical, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or get Surefire Medical, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 10 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 1, 2018 | Westminster, CO | Devices | Voluntary Action Indicated (VAI) | 3010909876 |
| Jun 22, 2012 | Miami, FL | Devices | No Action Indicated (NAI) | 3009428975 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K180677 | Surefire Spark Infusion System | Apr 3, 2018 |
| K171355 | Surefire Precision Infusion System | May 17, 2017 |
| K162359 | Surefire Guiding Catheter | Sep 21, 2016 |
| K160662 | Surefire Infusion System | Mar 11, 2016 |
| K143588 | Surefire Infusion System 021 | Jan 12, 2015 |
| K140034 | SUREFIRE GUIDING CATHETER | Feb 26, 2014 |
| K122506 | SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS | Sep 17, 2012 |
| K121677 | SUREFIRE HI-FLOW MICROCATHETER | Jun 14, 2012 |
| K113737 | SUREFIRE GUIDE SHEATH | Feb 23, 2012 |
| K110459 | SUREFIRE INFUSION CATHETER SYSTEM | Jun 24, 2011 |