# K011122: Ballpen Spinal Needle W/WO Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Nov 16, 2001 after 218 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112515: Pencan Spinal Needle (2011), 6 descendants of its own
- K141126: Uniever Disposable Spinal Anesthesia Needle (2014), 3 descendants of its own
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (2018), 2 descendants of its own
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K212982: Medispine - Spinal Needle, Glospine - Spinal Needle (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K011122
Methodology: https://510kreport.com/methodology