# K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
- Decided: Jan 5, 2018 after 226 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: 6 generations back to K932249 (1993). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle, Unisis Corp. (2015) Summary page 6.
- K141126: Uniever Disposable Spinal Anesthesia Needle, Unisis Corp. (2014) Summary page 6.
- K993619: Csecure Combined Spinal/Epidural Anesthesia System with Lock, Sims Portex, Inc. (2000) Summary page 6.

## Most influential descendants
- 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 Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space. The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

Source page: https://510kreport.com/device/K171518
Methodology: https://510kreport.com/methodology