# K192421: EpiFaith Syringe

- Pathway: 510(k) (Special)
- Applicant: Flat Medical Co., Ltd.
- Decided: Sep 27, 2019 after 23 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
Longest line of descent: 1 generation back to K182268 (2019). 1 ancestor in all.
1 later device descends 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)
- K182268: EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit), Flat Medical Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K233056: EpiZact (2023), 0 descendants of its own

## Indications for use
EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Source page: https://510kreport.com/device/K192421
Methodology: https://510kreport.com/methodology