510(k) Report

FDA applicant

Vascular Technology Incorporated

Attleboro, MA11 decisions1985–20085 recalls

FDA records 11 decisions for Vascular Technology Incorporated (Attleboro, MA) from 1985 to 2008: 11 510(k) clearances. Most are in product codes CCL (Analyzer, Gas, Oxygen, Gaseous-Phase) and DPW (Flowmeter, Blood, Cardiovascular). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Vascular Technology Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

1in 2018

2014: 42018: 1
2007high 4 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase4decisions
  • DPWFlowmeter, Blood, Cardiovascular2decisions
  • DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass1decision
  • HBLHolder, Head, Neurosurgical (Skull Clamp)1decision
  • CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling1decision
  • FFTElectrode, Ph, Stomach1decision

Also: DQK (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K082870Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 20082cite it
  • K862113NO. 100352 Galvanic Oxygen SensorVascular Technology Incorporated · 19861cites it
  • K862114Khuri Regional Tissue PH MonitorVascular Technology Incorporated · 19861cites it

What has FDA decided for it lately?

  • K082870Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 20084 recalls
  • K031091Vti 20 MHZ Gated DopplerVascular Technology Incorporated · 20031 recall
  • K002990Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001Vascular Technology Incorporated · 2000
  • K944764Vti Disposable Pressure Display SetVascular Technology Incorporated · 1994
  • K922738Vti Oxygen AnalyzerVascular Technology Incorporated · 1993
  • K890058Vascular Technology Uniox Oxygen AlarmVascular Technology Incorporated · 1989
  • K883960Giphy MonitorVascular Technology Incorporated · 1989
  • K864583Cardiac Performance MonitorVascular Technology Incorporated · 1987

All 11 as Vascular Technology Incorporated →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K031091VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910…Jun 19, 2018Class II
  • K08287007-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is…May 28, 2014Class II
  • K08287007-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended…May 28, 2014Class II
  • K08287007-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended…May 28, 2014Class II
  • K082870VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is…May 28, 2014Class II