# K243525: SonoTAP and SonoTAP II

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Mar 24, 2025 after 130 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: 4 generations back to K932249 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113207: Sono Tap, Tuohy Sono, Pajunk GmbH (2012) Summary page 7.

## Indications for use
The SonoTAP and SonoTAP Il anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

Source page: https://510kreport.com/device/K243525
Methodology: https://510kreport.com/methodology