Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sight Sciences, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
254 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026-08-04 | 252 | 0 |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026-04-27 | 269 | 0 |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025-04-15 | 211 | 0 |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023-12-27 | 254 | 0 |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023-08-25 | 30 | 0 |
| K213045 | TearCare System | Sight Sciences, Inc. | 2021-12-21 | 90 | 0 |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021-03-01 | 167 | 0 |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020-08-11 | 28 | 0 |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017-12-21 | 59 | 0 |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017-07-27 | 31 | 0 |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014-12-05 | 28 | 0 |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | 2013-10-22 | 74 | 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