Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lutech Industries, Inc. — 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) |
|---|---|---|---|---|---|
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | 2017-05-21 | 96 | 0 |
| K160380 | LT-300 HD | Lutech Industries, Inc. | 2016-05-13 | 93 | 0 |
| K150691 | Datalys Multi-Parameter Patient Monitor | Lutech Industries, Inc. | 2015-05-15 | 58 | 0 |
| K143119 | LT-300 Video Colposcope | Lutech Industries, Inc. | 2014-12-18 | 49 | 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