Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brivant, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
263 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122856 | CHARTER GUIDEWIRE | Brivant, Ltd. | 2012-10-17 | 29 | 0 |
| K120137 | VICTORY GUIDEWIRE (32 MODELS) | Brivant, Ltd. | 2012-02-14 | 28 | 0 |
| K103377 | CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 | Brivant, Ltd. | 2011-05-18 | 182 | 0 |
| K102211 | CRUISER 18 GUIDEWIRE | Brivant, Ltd. | 2010-09-03 | 29 | 0 |
| K093515 | 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG T | Brivant, Ltd. | 2010-02-16 | 95 | 0 |
| K083094 | STREAMER POLYMER GUIDEWIRE | Brivant, Ltd. | 2009-07-07 | 263 | 0 |
| K073082 | CPS COURIER GUIDEWIRE | Brivant, Ltd. | 2008-01-09 | 69 | 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