# K080140: Laurimed Spinal Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Laurimed, LLC
- Decided: May 9, 2008 after 108 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: 3 generations back to K801941 (1980). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041843: Pencil Point Needle, Epimed International, Inc. (2004) Summary page 1.
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 1.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 1.
- K062005: Portex Epidural Catheter, Smiths Medical Asd, Inc. (2006) Summary page 1.

## Most influential descendants
- K083909: Spinal Injection System (2009), 1 descendant of its own
- K091818: Laurimed Spinal Injection System (2009), 0 descendants of its own

## Indications for use
Spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

Source page: https://510kreport.com/device/K080140
Methodology: https://510kreport.com/methodology