Belun Technology Company Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Belun Technology Company Limited” (first 2018, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 168 days. Since 2017 the median was 168 days, against 208 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 127 |
| 2019 | 1 | 135 |
| 2020 | 0 | — |
| 2021 | 1 | 168 |
| 2022 | 0 | — |
| 2023 | 1 | 182 |
| 2024 | 1 | 289 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Belun Technology Company Limited took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Belun Technology Company Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234110 | Belun Ring BLR-200 (BLR-200) | DQA | 2024-10-11 | 289 |
| K222579 | Belun Sleep System BLS-100 | MNR | 2023-02-23 | 182 |
| K211407 | Belun Ring BLR-100X | DQA | 2021-10-21 | 168 |
| K191417 | Belun Ring | DQA | 2019-10-10 | 135 |
| K180174 | Belun Ring | DQA | 2018-05-29 | 127 |
Recalls
openFDA lists no recalls under a recalling firm named Belun Technology Company Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Belun Technology Company Limited?
FDA lists 5 510(k) clearances under the applicant name “Belun Technology Company Limited” (first 2018, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Belun Technology Company Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Belun Technology Company Limited is 168 days. Since 2017: 168 days, versus 208 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Belun Technology Company Limited?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 5 Belun Technology Company Limited clearances with predicates and recalls
- Run predicate analysis for product code DQA, Belun Technology Company Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.