Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioptics, 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) |
|---|---|---|---|---|---|
| K091928 | 10 X 10 VISION | Bioptics, Inc. | 2010-06-16 | 351 | 0 |
| K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | 2009-07-17 | 50 | 0 |
| K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2008-11-21 | 91 | 0 |
| K052433 | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2005-10-18 | 42 | 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