# K100241: Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 16, 2010 after 79 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 K840287 (1984). 13 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090995: B. Braun Contiplex Continuous Nerve Block Set, B.Braun Medical, Inc. (2009) Summary page 1.
- K063380: Echostim Facet Tip, Havel'S, Inc. (2007) Summary page 1.

## Most influential descendants
- K173763: iovera system (2018), 2 descendants of its own
- K121846: Contiplex C Continuous Peripheral Nerve Block Needle (2012), 2 descendants of its own
- K220656: iovera System (2022), 1 descendant of its own
- K243677: iovera° System (2024), 0 descendants of its own
- K192914: Stimuplex Onvision System (2020), 0 descendants of its own

## Indications for use
The B. Braun Stimuplex® D Plus Insulated Echogenic Needle is intended for use in regional anesthesia and pain therapy to target peripheral nerves by transferring electrical impulses from a nerve stimulator and for visualization of an echogenic reflective pattern at the needle tip using an ultrasound imaging device. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery. The B. Braun Stimuplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate by stimulation peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery. The B. Braun Contiplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate, by stimulation, peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery. The Contiplex D Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The Contiplex D polyamide indwelling catheter may remain indwelling for up to 72 hours.

Source page: https://510kreport.com/device/K100241
Methodology: https://510kreport.com/methodology