# K040525: Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000

- Pathway: 510(k) (Traditional)
- Applicant: Sontra Medical, Inc.
- Decided: Aug 17, 2004 after 169 days
- Product code: NRJ (Ultrasound, Skin Permeation)
- Device class: 2
- Regulation: 21 CFR 878.4410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934335 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023713: Sonoprep Impedance Diagnostics (Idx) System, Model D1000, Sontra Medical, Inc. (2004) Summary page 1.
- K021222: Lad, Model Lad-01, Norwood Abbey, Ltd. (2003) Summary page 1.

## Indications for use
The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and Procedure Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.

Source page: https://510kreport.com/device/K040525
Methodology: https://510kreport.com/methodology