Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vision Rt, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
213 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026-03-18 | 180 | 0 |
| K243301 | MapRT | Vision Rt, Ltd. | 2025-05-19 | 213 | 0 |
| K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024-03-29 | 137 | 0 |
| K231185 | MapRT | Vision Rt, Ltd. | 2023-06-23 | 58 | 0 |
| K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021-11-10 | 86 | 0 |
| K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021-03-04 | 106 | 0 |
| K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020-01-03 | 24 | 0 |
| K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018-08-07 | 92 | 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