Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen HugeMed Medical Technical Development Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
207 daysmedian FDA review time
287 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 | 57 | 0 |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-07-08 | 123 | 0 |
| K241444 | Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-01-21 | 244 | 0 |
| K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 | 93 | 0 |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 | 256 | 0 |
| K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-03-06 | 287 | 0 |
| K231118 | Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 | 207 | 0 |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-04-11 | 197 | 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