# K182268: EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

- Pathway: 510(k) (Traditional)
- Applicant: Flat Medical Co., Ltd.
- Decided: Apr 5, 2019 after 227 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K192421: EpiFaith Syringe (2019), 1 descendant of its own
- K233056: EpiZact (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K182268
Methodology: https://510kreport.com/methodology