# K072005: RK Epidural Needle

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International
- Decided: Feb 7, 2008 after 199 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: 3 generations back to K980536 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030562: Tuohy Epidural Needle, Epimed International, Inc. (2003) Summary page 1.
- K053318: RX Epidural Needle, Epimed International, Inc. (2006) Summary page 1.

## Recalls of this device
- Apr 22, 2016 · Class II · Z-0086-2017: There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patie

## Indications for use
The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.

Source page: https://510kreport.com/device/K072005
Methodology: https://510kreport.com/methodology