Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bolder Surgical, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
219 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231012 | CoolSeal Trinity | Bolder Surgical, LLC | 2023-11-15 | 219 | 0 |
| K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaf | Bolder Surgical, LLC | 2021-09-07 | 109 | 0 |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | Bolder Surgical, LLC | 2021-05-06 | 191 | 0 |
| K203640 | CoolSeal Reveal | Bolder Surgical, LLC | 2021-05-06 | 143 | 0 |
| K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft | Bolder Surgical, LLC | 2020-10-06 | 68 | 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