Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smylio, 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) |
|---|---|---|---|---|---|
| K260788 | Smylio Aligners | Smylio, Inc. | 2026-05-08 | 59 | 0 |
| K221537 | Nightwear Aligners | Smylio, Inc. | 2023-04-05 | 313 | 0 |
| K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021-09-22 | 30 | 0 |
| K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | 2018-08-23 | 253 | 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