Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biohytech International, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
79 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870453 | DS-DNA EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-24 | 62 | 0 |
| K870457 | RNP EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | 55 | 0 |
| K870456 | DNP EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | 55 | 0 |
| K870455 | SM EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | 55 | 0 |
| K870452 | SS-DNA EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | 55 | 0 |
| K870458 | HISTONES EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | 55 | 0 |
| K862969 | ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT | Biohytech International, Inc. | 1986-10-24 | 79 | 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