510(k) Report

FDA applicant

Hemedex Incorporated

Hopkonton, MA4 decisions2002–20140 recalls

FDA records 4 decisions for Hemedex Incorporated (Hopkonton, MA) from 2002 to 2014: 4 510(k) clearances. Most are in product codes GWM (Device, Monitoring, Intracranial Pressure) and DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 11 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, neurology panel, where it files most

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

FDA decisions per year

1in 2014

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hemedex 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?

  • GWMDevice, Monitoring, Intracranial Pressure2decisions
  • DPWFlowmeter, Blood, Cardiovascular1decision
  • KNYAccessories, Catheter, G-U1decision

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated · 20031cites it

What has FDA decided for it lately?

  • K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated · 2014
  • K032127Hemedex Fixation DeviceHemedex Incorporated · 2003
  • K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated · 2003
  • K013376Qflow 500 Perfusion Monitoring SystemHemedex Incorporated · 2002

All 4 as Hemedex Incorporated →