Hantech Medical Device Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hantech Medical Device Co., Ltd.” (first 2022, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 174 days. Since 2017 the median was 174 days, against 149 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 160 |
| 2023 | 3 | 181 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hantech Medical Device Co., Ltd. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| NGT | Saline, Vascular Access Flush | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Hantech Medical Device Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | NGT | 2023-09-27 | 139 |
| K222739 | Disposable Insulin Pen Needle | FMI | 2023-04-06 | 209 |
| K222672 | Disposable Insulin Syringe | FMF | 2023-03-06 | 181 |
| K221038 | Disposable Medical Masks | FXX | 2022-09-01 | 147 |
| K220603 | Disposable Medical Safety Hypodermic Needle | FMI | 2022-08-23 | 174 |
Recalls
openFDA lists no recalls under a recalling firm named Hantech Medical Device Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hantech Medical Device Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Hantech Medical Device Co., Ltd.” (first 2022, latest 2023), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hantech Medical Device Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hantech Medical Device Co., Ltd. is 174 days. Since 2017: 174 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hantech Medical Device Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); FMF (Syringe, Piston, 1); FXX (Mask, Surgical, 1).
Next steps
- See all 5 Hantech Medical Device Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Hantech Medical Device Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.