# K073222: Modification to:Specialty Needles

- Pathway: 510(k) (Special)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Apr 9, 2008 after 146 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: 2 generations back to K895771 (1990). 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)
- K061394: Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle), Busse Hospital Disposables, Inc. (2006) Summary page 1.

## 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/K073222
Methodology: https://510kreport.com/methodology