Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Threadstone, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 | 83 | 0 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 | 244 | 0 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 | 86 | 0 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 | 140 | 0 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 | 294 | 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