# K183316: Dr J Spinal and Epidural Needles

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Japan Co., Ltd.
- Decided: Aug 12, 2019 after 255 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 K990519 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990519: Phoenix Epidural & Spinal Needles, Myco Medical Supplies, Inc. (2000) Summary page 4.

## Most influential descendants
- K203668: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (2021), 0 descendants of its own

## Indications for use
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia

Source page: https://510kreport.com/device/K183316
Methodology: https://510kreport.com/methodology