Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rxsight, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026-06-10 | 62 | 0 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023-08-15 | 54 | 0 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023-06-12 | 24 | 0 |
| K201909 | RxSight Contact Lens | Rxsight, Inc. | 2020-09-10 | 63 | 0 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020-01-17 | 93 | 0 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018-07-26 | 58 | 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