510(k) Report

FDA applicant

Intrgra Lifesciences Corporation

Planisboro, NJ1 decision2012–20123 recalls

FDA records 1 decision for Intrgra Lifesciences Corporation (Planisboro, NJ) in 2012: 1 510(k) clearance. All are in product code GWM (Device, Monitoring, Intracranial Pressure). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 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, neurology panel, where it files most

How often FDA has decided Intrgra Lifesciences Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2015

2015: 3
2012high 3 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Intrgra Lifesciences Corporation by year, 2012–2026Sources: 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 Pressure1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K121573Integra Camino Icp MonitorIntrgra Lifesciences Corporation · 20123cite it

What has FDA decided for it lately?

  • K121573Integra Camino Icp MonitorIntrgra Lifesciences Corporation · 20123 recalls

The one decision as Intrgra Lifesciences Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K121573The Integra Licox Pt02 Monitors are compact, portable device for use with…Apr 14, 2015Class II
  • K121573The Integra Camino ICP Monitor is a compact, portable device for use with…Apr 14, 2015Class II
  • K121573The Integra Licox Pt02 Monitors are compact, portable device for use with…Apr 14, 2015Class II