Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Focus Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | Focus Technologies, Inc. | 2004-06-30 | 90 | 0 |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Focus Technologies, Inc. | 2003-10-22 | 119 | 0 |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Focus Technologies, Inc. | 2003-10-22 | 119 | 1 |
| K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G | Focus Technologies, Inc. | 2002-08-01 | 90 | 0 |
| K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G | Focus Technologies, Inc. | 2002-07-29 | 87 | 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