Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tecan U.S., 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) |
|---|---|---|---|---|---|
| K963268 | GENESIS RMP | Tecan U.S., Inc. | 1997-03-18 | 210 | 0 |
| K953345 | GENESIS | Tecan U.S., Inc. | 1995-11-21 | 132 | 3 |
| K944556 | 4 CHANNEL DISPENSER | Tecan U.S., Inc. | 1994-10-25 | 39 | 0 |
| K942655 | 4 CHANNEL DISPENSER | Tecan U.S., Inc. | 1994-09-02 | 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