# K151072: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

- Pathway: 510(k) (Traditional)
- Applicant: Solo-Dex, Inc.
- Decided: Jan 22, 2016 after 276 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: 8 generations back to K840287 (1984). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121846: Contiplex C Continuous Peripheral Nerve Block Needle, B.Braun Medical, Inc. (2012) Summary page 4.

## Indications for use
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous and/or intermittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures. In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, peri-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.

Source page: https://510kreport.com/device/K151072
Methodology: https://510kreport.com/methodology