Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Luxtron · 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) |
|---|---|---|---|---|---|
| K923189 | LUXTRON MODEL 3100/3101/3102 MULTICHANNEL | Luxtron | 1994-03-28 | 636 | 0 |
| K861623 | MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER | Luxtron | 1986-08-19 | 112 | 0 |
| K841105 | MULTICHANNEL 2000 FLUOROPTIC THERMOMET | Luxtron | 1984-07-03 | 111 | 0 |
| K821070 | BIOMEDICAL FLUOROPTIC | Luxtron | 1982-07-13 | 88 | 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