Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ray Co., Ltd. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
259 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260462 | RCT800 | Ray Co., Ltd. | 2026-04-09 | 56 | 0 |
| K251798 | RCT700 | Ray Co., Ltd. | 2025-11-25 | 166 | 0 |
| K251109 | SMARTDent | Ray Co., Ltd. | 2025-05-21 | 40 | 0 |
| K243903 | RCT600 | Ray Co., Ltd. | 2025-03-12 | 83 | 0 |
| K233625 | RAYDENT SW | Ray Co., Ltd. | 2024-05-16 | 185 | 0 |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024-04-18 | 259 | 0 |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2023-08-31 | 30 | 0 |
| K230753 | RCT800 | Ray Co., Ltd. | 2023-04-11 | 25 | 0 |
| K213226 | RCT700 | Ray Co., Ltd. | 2021-11-29 | 61 | 0 |
| K211105 | Ear-Friendly Mask | Ray Co., Ltd. | 2021-05-17 | 34 | 0 |
| K192737 | RCT800 | Ray Co., Ltd. | 2019-10-22 | 25 | 0 |
| K190812 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2019-04-24 | 26 | 0 |
| K182805 | RCT800 | Ray Co., Ltd. | 2018-12-14 | 73 | 0 |
| K182614 | RCT700 | Ray Co., Ltd. | 2018-10-16 | 25 | 0 |
| K181452 | RCT800 | Ray Co., Ltd. | 2018-07-27 | 56 | 0 |
| K160525 | RCT700 | Ray Co., Ltd. | 2016-06-20 | 116 | 0 |
| K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016-04-15 | 24 | 0 |
| K142058 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2015-04-22 | 267 | 0 |
| K142247 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2015-04-17 | 262 | 0 |
| K143000 | RIS500 | Ray Co., Ltd. | 2015-01-23 | 98 | 0 |
| K131695 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2013-11-01 | 144 | 0 |
| K131693 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2013-11-01 | 144 | 0 |
| K122918 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2013-03-15 | 172 | 0 |
| K122981 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2013-03-12 | 169 | 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