Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioptigen, 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) |
|---|---|---|---|---|---|
| K162783 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2016-12-09 | 67 | 0 |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015-12-02 | 257 | 0 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012-05-11 | 123 | 0 |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | 2006-12-13 | 37 | 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