Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunny Medical Device (Shenzhen) Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
296 daysmedian FDA review time
401 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 | 252 | 0 |
| K160190 | Sunmed Control Syringes | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-11-10 | 288 | 0 |
| K153685 | Sunmed Haemostatic Valves | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-10-13 | 296 | 0 |
| K140356 | SUMMED HIGH PRESSURE LINE | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015-03-20 | 401 | 0 |
| K133795 | SUMMED INFLATION DEVICE KIT | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014-12-12 | 364 | 0 |
| K120119 | SUNMED GUIDE WIRE | Sunny Medical Device (Shenzhen) Co., Ltd. | 2012-05-11 | 115 | 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