510(k) Report

FDA applicant

Vectracor, Inc.

Totowa, NJ3 decisions2011–20180 recalls

FDA records 3 decisions for Vectracor, Inc. (Totowa, NJ) from 2011 to 2018: 3 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MSX (System, Network And Communication…). Its devices cite 7 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2018

2011: 12015: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Vectracor, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vectracor, 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?

  • DPSElectrocardiograph2decisions
  • MSXSystem, Network And Communication, Physiological Monitors1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K102378Vectraplexecg System with VectraplexamiVectracor, Inc. · 20111cites it
  • K173952Universal SmartECGVectracor, Inc. · 20181cites it

What has FDA decided for it lately?

  • K173952Universal SmartECGVectracor, Inc. · 2018
  • K140852Vectraplex CMSVectracor, Inc. · 2015
  • K102378Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011

All 3 as Vectracor, Inc. →