Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fox Hollow Technologies — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071432 | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL | Fox Hollow Technologies | 2008-02-12 | 265 | 0 |
| K071826 | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 | Fox Hollow Technologies | 2007-11-09 | 129 | 0 |
| K053460 | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | Fox Hollow Technologies | 2006-01-13 | 31 | 0 |
| K043553 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,0 | Fox Hollow Technologies | 2005-02-18 | 53 | 0 |
| K024243 | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIP | Fox Hollow Technologies | 2003-06-20 | 179 | 1 |
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