# K093863: Epidrum

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: May 10, 2010 after 144 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 K001731 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001731: Avid-Nit Loss of Resistance Syringe, Avid Medical, Inc. (2000) Summary page 2.

## Most influential descendants
- K161883: CompuFlo Epidural Computer Controlled Anesthesia System (2017), 1 descendant of its own
- K221974: EpiFinder (2023), 0 descendants of its own
- K221702: CompuFlo Epidural Computer Controlled Anesthesia System (2023), 0 descendants of its own

## Indications for use
The Epidrum is intended far use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.

Source page: https://510kreport.com/device/K093863
Methodology: https://510kreport.com/methodology