Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radius Medical Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
225 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070502 | RADIUS SNARE | Radius Medical Technologies, Inc. | 2007-10-04 | 225 | 0 |
| K071457 | MODIFICATION TO RADIUS SNARE | Radius Medical Technologies, Inc. | 2007-09-25 | 123 | 0 |
| K032899 | RADIUS COUGAR WIRE | Radius Medical Technologies, Inc. | 2003-10-17 | 30 | 2 |
| K032129 | RADIUS 018 COUGAR WIRE | Radius Medical Technologies, Inc. | 2003-07-17 | 7 | 0 |
| K022201 | RADIUS MICRO SNARE | Radius Medical Technologies, Inc. | 2003-02-03 | 213 | 0 |
| K021441 | RADIUS SNARE | Radius Medical Technologies, Inc. | 2002-06-14 | 39 | 0 |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | Radius Medical Technologies, Inc. | 2001-08-23 | 78 | 0 |
| K011287 | RADIUS COUGAR WIRE | Radius Medical Technologies, Inc. | 2001-05-25 | 28 | 0 |
| K970466 | RADIUS PTCA GUIDEWIRE | Radius Medical Technologies, Inc. | 1997-05-20 | 102 | 2 |
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