Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Hulu Devices 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) |
|---|---|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethos | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 | 86 | 0 |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | 2022-05-23 | 94 | 0 |
| K180335 | Accutension Smartphone Auscultatory Blood | Shanghai Hulu Devices Co., Ltd. | 2018-03-08 | 30 | 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