# K030562: Tuohy Epidural Needle

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Apr 3, 2003 after 41 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980536 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980536: Epidural Needle, Manan Medical Products, Inc. (1998) Summary page 1.

## Most influential descendants
- K053318: RX Epidural Needle (2006), 1 descendant of its own
- K072005: RK Epidural Needle (2008), 0 descendants of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0089-2018: Potential for partially incomplete seal of product, impacting sterility.

## Indications for use
The Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

Source page: https://510kreport.com/device/K030562
Methodology: https://510kreport.com/methodology