# K151069: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Feb 5, 2016 after 290 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 K840287 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063380: Echostim Facet Tip, Havel'S, Inc. (2007) Summary page 4.

## Indications for use
The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or extension set.

Source page: https://510kreport.com/device/K151069
Methodology: https://510kreport.com/methodology