# Flat Medical Co., Ltd.

- Location (FDA's records): Taipei, TW
- FDA decisions: 3 (2019–2022): 3 510(k) clearances
- Product codes: FMF (2), DQX (1)
- 510(k) review time since 2016: median 227 days, against 146 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 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
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)

## Firms that cite its devices most
- Guidestar Medical Devices: 1 (https://510kreport.com/company/guidestar-medical-devices)

## Its most-cited devices
- K182268: EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) (2019), cited by 1
- K192421: EpiFaith Syringe (2019), cited by 1

## Recent decisions
- K212615: EpiFaith CV (Sep 21, 2022)
- K192421: EpiFaith Syringe (Sep 27, 2019)
- K182268: EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) (Apr 5, 2019)

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