Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atlantic Optical Systems, 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) |
|---|---|---|---|---|---|
| K850532 | ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK | Atlantic Optical Systems, Inc. | 1985-04-15 | 63 | 0 |
| K850533 | ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM | Atlantic Optical Systems, Inc. | 1985-03-21 | 38 | 0 |
| K834155 | UNIVERSAL PACK | Atlantic Optical Systems, Inc. | 1984-06-19 | 200 | 0 |
| K831701 | UNIVERSAL PACK | Atlantic Optical Systems, Inc. | 1983-07-12 | 48 | 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