Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solos Ophthalmology — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874334 | SOLOS SINGLE USE TITANIUM TIP | Solos Ophthalmology | 1988-01-11 | 81 | 0 |
| K872611 | SOLOS EYESITE CAP SLEEVE | Solos Ophthalmology | 1987-08-10 | 35 | 0 |
| K872612 | SOLOS EYESITE SPONGES | Solos Ophthalmology | 1987-07-31 | 25 | 0 |
| K872610 | SOLOS EYESITE CANNULAS | Solos Ophthalmology | 1987-07-31 | 25 | 0 |
| K872620 | SOLOS EYESITE DRAPES | Solos Ophthalmology | 1987-07-31 | 25 | 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