Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYD — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911734 | TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM | Northland Cataract & Eye Care Clinic | 1991-11-07 | 204 | 0 |
| K881515 | TEAR VOLUME TESTS | Visionex, Inc. | 1988-05-23 | 42 | 0 |
| K832181 | SNO STRIPS STERILE TEARFLOW TEST STRIP | Smith & Nephew, Inc. | 1983-08-12 | 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