# K192914: Stimuplex Onvision System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 27, 2020 after 225 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 K911783 (1994). 67 ancestors in all.
No later device cites it as a predicate yet.
7 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121812: Sonixgps, Ultrasonix Medical Corporation (2013) Summary page 4.
- K170716: PercuNav Image Fusion and Interventional Navigation, Philips Ultrasound, Inc. (2017) Summary page 4.
- K100241: Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680, B.Braun Medical, Inc. (2010) Summary page 4.

## Indications for use
The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.

Source page: https://510kreport.com/device/K192914
Methodology: https://510kreport.com/methodology