510(k) Report

FDA applicant

Confidant, Inc.

Durham, NC3 decisions2006–20090 recalls

FDA records 3 decisions for Confidant, Inc. (Durham, NC) from 2006 to 2009: 3 510(k) clearances. All are in product code DRG (Transmitters And Receivers, Physiological…). Its devices cite 4 predicates, 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Confidant, 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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072698Confidant 2.5Confidant, Inc. · 20078cite it
  • K083331Confidant, Model 2.6Confidant, Inc. · 20092cite it
  • K062215Confidant 2.0Confidant, Inc. · 20061cites it

What has FDA decided for it lately?

  • K083331Confidant, Model 2.6Confidant, Inc. · 2009
  • K072698Confidant 2.5Confidant, Inc. · 2007
  • K062215Confidant 2.0Confidant, Inc. · 2006

All 3 as Confidant, Inc. →