Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hsiner Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
379 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 | 265 | 0 |
| K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SIL | Hsiner Co., Ltd. | 2011-08-12 | 379 | 0 |
| K091185 | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRA | Hsiner Co., Ltd. | 2009-07-24 | 92 | 0 |
| K082009 | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS | Hsiner Co., Ltd. | 2008-08-22 | 30 | 0 |
| K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | Hsiner Co., Ltd. | 2007-02-23 | 116 | 1 |
| K053466 | HSINER RESUSCITATOR | Hsiner Co., Ltd. | 2006-03-22 | 99 | 0 |
| K052811 | HSINER JET NEBULIZER, MODEL HS-31100 | Hsiner Co., Ltd. | 2005-12-21 | 78 | 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