Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bonraybio Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
253 daysmedian FDA review time
282 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE | Bonraybio Co., Ltd. | 2025-05-30 | 253 | 0 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 | 270 | 0 |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm S | Bonraybio Co., Ltd. | 2022-10-31 | 131 | 0 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE | Bonraybio Co., Ltd. | 2020-10-28 | 92 | 0 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen | Bonraybio Co., Ltd. | 2018-11-16 | 282 | 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