510(k) Report

FDA applicant

Sontra Medical, Inc.

Franklin, MA2 decisions2004–20040 recalls

FDA records 2 decisions for Sontra Medical, Inc. (Franklin, MA) in 2004: 2 510(k) clearances. Most are in product codes NRJ (Ultrasound, Skin Permeation) and KRC (Tester, Electrode, Surface, Electrocardiographic). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Sontra Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sontra Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sontra Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sontra Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NRJUltrasound, Skin Permeation1decision
  • KRCTester, Electrode, Surface, Electrocardiographic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023713Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc. · 20041cites it

What has FDA decided for it lately?

  • K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004
  • K023713Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc. · 2004

All 2 as Sontra Medical, Inc. →