# K221974: EpiFinder

- Pathway: 510(k) (Traditional)
- Applicant: Omeq Medical, Ltd.
- Decided: Apr 16, 2023 after 285 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: 2 generations back to K001731 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093863: Epidrum, Exmoor Plastics, Ltd. (2010) Summary page 4.

## Indications for use
The EpiFinder is intended for use, in between a luer Loss of resistance (LOR) syringe and an epidural needle, to verify the needle tip placement in the epidural space as a secondary indicator adjunctive to the LOR technique.

Source page: https://510kreport.com/device/K221974
Methodology: https://510kreport.com/methodology