Bonraybio Co., Ltd.: FDA clearances and approvals
Bonraybio Co., Ltd. has 5 FDA 510(k) clearances (first 2018, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time: 253 days. Since 2017 its median was 253 days, against 175 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 282 |
| 2019 | 0 | — |
| 2020 | 1 | 92 |
| 2021 | 0 | — |
| 2022 | 1 | 131 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 262 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bonraybio Co., Ltd.'s cleared 510(k)s took a median 253 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POV | Semen Analysis Device | 4 | 4 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Bonraybio Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | POV | 2025-05-30 | 253 |
| K242388 | LensHooke X12 PRO Semen Analysis System | POV | 2025-05-09 | 270 |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | MQK | 2022-10-31 | 131 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | POV | 2020-10-28 | 92 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | POV | 2018-11-16 | 282 |
Recalls
openFDA lists no recalls under a recalling firm named Bonraybio Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bonraybio Co., Ltd. have?
Bonraybio Co., Ltd. has 5 FDA 510(k) clearances (first 2018, latest 2025), across 2 product codes in 2 review panels.
How long does FDA take to clear Bonraybio Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bonraybio Co., Ltd.'s cleared 510(k)s is 253 days. Since 2017: 253 days, versus 175 days for all cleared 510(k)s in the same product codes.
What devices does Bonraybio Co., Ltd. make?
Its most frequent FDA product codes are POV (Semen Analysis Device, 4); MQK (Labware, Assisted Reproduction, 1).
Has Bonraybio Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bonraybio Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Bonraybio Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code POV, Bonraybio Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.