510(k) Report

FDA applicant

Vasomedical, Inc.

Westbury, NY7 decisions2000–20110 recalls

FDA records 7 decisions for Vasomedical, Inc. (Westbury, NY) from 2000 to 2011: 7 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and DRN (Device, Counter-Pulsating, External). Its devices cite 9 predicates, 5 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 Vasomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2009: 12010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vasomedical, 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?

  • DSHRecorder, Magnetic Tape, Medical4decisions
  • DRNDevice, Counter-Pulsating, External3decisions

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 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.

  • K020857Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External…Vasomedical, Inc. · 20025cite it
  • K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc. · 20093cite it
  • K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301Vasomedical, Inc. · 20102cite it
  • K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox…Vasomedical, Inc. · 20111cites it
  • K003469Eecp Therapy System, Model TS3Vasomedical, Inc. · 20001cites it

What has FDA decided for it lately?

  • K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel…Vasomedical, Inc. · 2011
  • K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox…Vasomedical, Inc. · 2011
  • K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301Vasomedical, Inc. · 2010
  • K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc. · 2009
  • K033617Eecp Therapy System Model TS4 with/Without Pluse OximetryVasomedical, Inc. · 2004
  • K020857Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External…Vasomedical, Inc. · 2002
  • K003469Eecp Therapy System, Model TS3Vasomedical, Inc. · 2000

All 7 as Vasomedical, Inc. →