Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Belun Technology Company Limited · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
289 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | 2024-10-11 | 289 | 0 |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023-02-23 | 182 | 0 |
| K211407 | Belun Ring BLR-100X | Belun Technology Company Limited | 2021-10-21 | 168 | 0 |
| K191417 | Belun Ring | Belun Technology Company Limited | 2019-10-10 | 135 | 0 |
| K180174 | Belun Ring | Belun Technology Company Limited | 2018-05-29 | 127 | 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