Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QUW — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-06-09 | 25 | 0 |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | 2025-07-15 | 350 | 0 |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025-05-30 | 56 | 0 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-12-27 | 90 | 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