Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Focus Diagnostics — 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) |
|---|---|---|---|---|---|
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Contr | Focus Diagnostics | 2015-08-28 | 140 | 2 |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positiv | Focus Diagnostics | 2014-12-05 | 102 | 0 |
| K141458 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | Focus Diagnostics | 2014-07-01 | 29 | 2 |
| DEN130049 | SIMPLEXA HSV 1&2 DIRECT | Focus Diagnostics | 2014-03-21 | 116 | 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