510(k) Report

FDA applicant

Vasocom, Inc.

Bristol, PA3 decisions2008–20140 recalls

FDA records 3 decisions for Vasocom, Inc. (Bristol, PA) from 2008 to 2014: 3 510(k) clearances. All are in product code DSB (Plethysmograph, Impedance). Its devices cite 3 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 Vasocom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12010: 12014: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Vasocom, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vasocom, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DSBPlethysmograph, Impedance3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K140102Physioflow Q-LinkVasocom, Inc. · 20142cite it
  • K103283Physioflow EnduroVasocom, Inc. · 20101cites it
  • K060387Physioflow SystemVasocom, Inc. · 20081cites it

What has FDA decided for it lately?

  • K140102Physioflow Q-LinkVasocom, Inc. · 2014
  • K103283Physioflow EnduroVasocom, Inc. · 2010
  • K060387Physioflow SystemVasocom, Inc. · 2008

All 3 as Vasocom, Inc. →