Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
ORZ — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
172 daysmedian FDA review time
269 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026-04-27 | 269 | 0 |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025-04-15 | 211 | 0 |
| K240512 | Tixel i (TXLI0001) | Novoxel , Ltd. | 2024-11-04 | 256 | 0 |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023-12-27 | 254 | 0 |
| K213045 | TearCare System | Sight Sciences, Inc. | 2021-12-21 | 90 | 0 |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | 2020-05-21 | 93 | 0 |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2019-10-22 | 29 | 0 |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017-12-26 | 116 | 0 |
| K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016-11-04 | 172 | 1 |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2013-12-23 | 84 | 2 |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2011-12-19 | 94 | 2 |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTE | Tearscience, Inc. | 2011-06-28 | 323 | 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