Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQT · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970320 | SCLERAL SHELL | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 | 160 | 0 |
| K970327 | SCLERAL SHELL | Southwest Artificial Eyes, Inc. | 1997-07-07 | 160 | 0 |
| K904961 | ARTIFICIAL SCLERAL SHELL | Midwest Eye Laboratories, Inc. | 1991-08-30 | 298 | 0 |
| K855105 | SIMMONS SHELL | Mira, Inc. | 1986-03-31 | 98 | 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