Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bion Ent., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
160 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | Bion Ent., Ltd. | 1993-06-15 | 196 | 1 |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | Bion Ent., Ltd. | 1990-04-05 | 30 | 0 |
| K894622 | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | 1989-10-24 | 96 | 0 |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K894624 | MUMPS VIRUS | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-08-31 | 160 | 0 |
| K894625 | CHLAMYDIA (LGV-1) | Bion Ent., Ltd. | 1989-08-15 | 26 | 0 |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-07-14 | 77 | 0 |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | Bion Ent., Ltd. | 1989-02-17 | 10 | 0 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-07 | 75 | 1 |
| K880679 | BION CMV-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-03 | 105 | 1 |
| K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | Bion Ent., Ltd. | 1987-08-17 | 28 | 0 |
| K800434 | PORTABLE MEDICAL ULTRASOUND SCANNER | Bion Ent., Ltd. | 1980-04-10 | 43 | 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