510(k) Report

FDA applicant

Transmed7, LLC

Portola Valley, CA2 decisions2018–20200 recalls

FDA records 2 decisions for Transmed7, LLC (Portola Valley, CA) from 2018 to 2020: 2 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Its devices cite 4 predicates, 0 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 Transmed7, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Transmed7, LLC by year, 2018–2026Sources: 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; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K201244Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy DevicesTransmed7, LLC · 2020
  • K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird…Transmed7, LLC · 2018

All 2 as Transmed7, LLC →