Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Linatech, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232489 | VenusX | Linatech, LLC | 2024-04-12 | 239 | 0 |
| K092550 | TIGRT IVS | Linatech, LLC | 2009-12-15 | 118 | 0 |
| K090893 | TIGRT TPS | Linatech, LLC | 2009-07-15 | 106 | 0 |
| K090802 | TIGRT MLC, TIGRT DMLC | Linatech, LLC | 2009-07-07 | 105 | 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