Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shining World Health Care 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) |
|---|---|---|---|---|---|
| K213317 | ShinEvac Smoke Evacuation Pencil | Shining World Health Care Co., Ltd. | 2022-01-28 | 116 | 0 |
| K031370 | SHINMED MODE SW-988 UNTRASONIC NEBULIZER | Shining World Health Care Co., Ltd. | 2004-09-01 | 490 | 0 |
| K033027 | SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, | Shining World Health Care Co., Ltd. | 2004-08-12 | 321 | 0 |
| K980024 | SHINMED MODEL SW-966 ULTRASONIC NEBULIZER | Shining World Health Care Co., Ltd. | 1999-09-03 | 606 | 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