Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bei Medical Systems Co., Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971492 | AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR | Bei Medical Systems Co., Inc. | 1997-09-05 | 134 | 0 |
| K950663 | BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR | Bei Medical Systems Co., Inc. | 1995-05-17 | 93 | 0 |
| K934286 | HYSTEROSCOPE | Bei Medical Systems Co., Inc. | 1994-07-19 | 320 | 0 |
| K940266 | BEI MEDICAL SYSTEMS' SMOKE EVACUATOR | Bei Medical Systems Co., Inc. | 1994-03-24 | 62 | 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