Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shinva Ande Healthcare Apparatus Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
293 daysmedian FDA review time
904 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-11-23 | 904 | 0 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 | 274 | 0 |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable St | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-03-01 | 293 | 0 |
| K202060 | Disposable IV catheter | Shinva Ande Healthcare Apparatus Co., Ltd. | 2021-07-23 | 361 | 0 |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 | 257 | 0 |
| K162601 | Infusion Set for Single Use | Shinva Ande Healthcare Apparatus Co., Ltd. | 2017-05-31 | 254 | 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