Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xiros, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
226 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023-05-31 | 82 | 0 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-12-27 | 90 | 0 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-08-26 | 226 | 0 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 | 115 | 0 |
| K211563 | Pitch-Patchs | Xiros, Ltd. | 2021-08-13 | 85 | 0 |
| K191053 | Xtreme-Loop | Xiros, Ltd. | 2019-07-17 | 89 | 0 |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | 2018-04-03 | 64 | 0 |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Xiros, Ltd. | 2017-06-30 | 24 | 0 |
| K151601 | SECURE-LOOP | Xiros, Ltd. | 2015-09-09 | 89 | 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