Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Metrix Teknika, 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) |
|---|---|---|---|---|---|
| K781803 | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Metrix Teknika, Inc. | 1979-01-17 | 86 | 0 |
| K781802 | WASHER SYSTEM, MICROELISA | Metrix Teknika, Inc. | 1978-12-20 | 58 | 0 |
| K781348 | FOCISCAN ECHOVISOR SYSTEM | Metrix Teknika, Inc. | 1978-10-03 | 57 | 0 |
| K780035 | MINIVISOR | Metrix Teknika, Inc. | 1978-03-06 | 56 | 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