# K061394: Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Sep 6, 2006 after 110 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K895771 (1990). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895771: Exel Spinal Needles, Exel Intl. (1990) Summary page 1.

## Most influential descendants
- K070354: Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) (2007), 7 descendants of its own
- K131006: Anesthesia Conduction Needles (2013), 5 descendants of its own
- K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (2015), 3 descendants of its own
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (2018), 2 descendants of its own
- K212982: Medispine - Spinal Needle, Glospine - Spinal Needle (2022), 0 descendants of its own

## Indications for use
specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Source page: https://510kreport.com/device/K061394
Methodology: https://510kreport.com/methodology