510(k) · Decided
DecidedSonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sontra Medical, Inc. · NRJ Ultrasound, Skin Permeation
Cleared on Aug 17, 2004 as substantially equivalent to K023713 (Sontra Medical, Inc., 2004) and 1 other predicate after a 169-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 17, 2004
- Review
- 169 days
- Class
- Class II
- Product code
- NRJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934335 (1994). 7 ancestors in all, the oldest K782079 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
- 2 generations backK974855 Phoresor II, Model PM900Iomed, Inc. · 1998
- 1 generation backK021222 Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
- This deviceK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934335 | Phoresor II Auto, Model PM800 Modification | Iomed, Inc. | 1994 | — |
| −2 | K974855 | Phoresor II, Model PM900 | Iomed, Inc. | 1998 | — |
| −1 | K021222 | Lad, Model Lad-01 | Norwood Abbey, Ltd. | 2003 | — |
| 0 (this device) | K040525 | Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model… | Sontra Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023713 | Sonoprep Impedance Diagnostics (Idx) System, Model D1000Summary page 1…510(k) SUMMARY The Sontra Medical, SonoPrep® Impedance Diagnostics (IDx) System, Predicate Devices K023713 and the Norwood Abbey, LAD-01, K021222, were selected as the predicate devices for this submission.… | 2004 |
| * | K021222 | Lad, Model Lad-01Summary page 1…RY The Sontra Medical, SonoPrep® Impedance Diagnostics (IDx) System, Predicate Devices K023713 and the Norwood Abbey, LAD-01, K021222, were selected as the predicate devices for this submission. The So… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All NRJ devicesNRJ Ultrasound, Skin Permeation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRJ
FDA has decided no NRJ device since 2007.
Median 510(k) review, days · NRJ
Too few NRJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NRJ
No recall names NRJ since 2007.
Adverse event reports per year · NRJ
No MAUDE report names NRJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040525: Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040525
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026