# K112515: Pencan Spinal Needle

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Dec 22, 2011 after 114 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 K820047 (1982). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932569: Pencil Point Spinal Needle and Tray, B. Braun of America, Inc. (1994) Summary page 1.
- K820047: Spinocan Spinal Needle, Burron Medical Products, Inc. (1982) Summary page 1.
- K011122: Ballpen Spinal Needle W/WO Introducer, Rusch Intl. (2001) Summary page 1.

## Most influential descendants
- 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
- K211085: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (2022), 0 descendants of its own

## Indications for use
The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient. The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.

Source page: https://510kreport.com/device/K112515
Methodology: https://510kreport.com/methodology