Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Homed Medical Device Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 | 125 | 0 |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 | 235 | 0 |
| K170886 | HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 | 451 | 0 |
| K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models J | Shenzhen Homed Medical Device Co., Ltd. | 2017-09-06 | 455 | 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