Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Crystalvue Medical Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021-04-13 | 78 | 0 |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019-01-02 | 141 | 0 |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018-12-14 | 260 | 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