Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hunan Endoso Life Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 | 203 | 0 |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | 2024-02-15 | 302 | 0 |
| K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd. | 2023-10-16 | 125 | 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