510(k) Report

FDA applicant

Sontina Medical, LLC

San Francisco, CA2 decisions2012–20140 recalls

FDA records 2 decisions for Sontina Medical, LLC (San Francisco, CA) from 2012 to 2014: 2 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Its devices cite 4 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2014

2012: 12014: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Sontina Medical, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K120440Presto Breast Biopsy DeviceSontina Medical, LLC · 20121cites it

What has FDA decided for it lately?

  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014
  • K120440Presto Breast Biopsy DeviceSontina Medical, LLC · 2012

All 2 as Sontina Medical, LLC →