# Hantech Medical Device Co., Ltd.

- Location (FDA's records): Ningbo, CN
- FDA decisions: 5 (2022–2023): 5 510(k) clearances
- Product codes: FMI (2), FMF (1), FXX (1), NGT (1)
- 510(k) review time since 2016: median 174 days, against 142 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Promisemed Hangzhou Meditech Co., Ltd.: 2 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- Anhui Tiankang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/anhui-tiankang-medical-technology)
- Hubei Yi-Ya Protective Products Co., Ltd.: 1 (https://510kreport.com/company/hubei-yi-ya-protective-products)
- Amsino International, Inc.: 1 (https://510kreport.com/company/amsino-international)

## Recent decisions
- K231363: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (Sep 27, 2023)
- K222739: Disposable Insulin Pen Needle (Apr 6, 2023)
- K222672: Disposable Insulin Syringe (Mar 6, 2023)
- K221038: Disposable Medical Masks (Sep 1, 2022)
- K220603: Disposable Medical Safety Hypodermic Needle (Aug 23, 2022)

Source page: https://510kreport.com/company/hantech-medical-device