Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hantech Medical Device Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
209 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models | Hantech Medical Device Co., Ltd. | 2023-09-27 | 139 | 0 |
| K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | 2023-04-06 | 209 | 0 |
| K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | 2023-03-06 | 181 | 0 |
| K221038 | Disposable Medical Masks | Hantech Medical Device Co., Ltd. | 2022-09-01 | 147 | 0 |
| K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | 2022-08-23 | 174 | 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