INTEGRA CAMINO ICP MONITOR— 510(k) K121573

Name: FDA 510(k) clearance K121573
Creator: U.S. Food and Drug Administration
Published: 2012-09-10

Substantially Equivalent

Intrgra Lifesciences Corporation

FDA 510(k) clearance K121573 for INTEGRA CAMINO ICP MONITOR, Substantially Equivalent on 2012-09-10. Applicant: Intrgra Lifesciences Corporation. Device class: 2.

Clearance details

Applicant: Intrgra Lifesciences Corporation
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 2012-05-29
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWM

view all

K252241 — Pressio 3 Multi-parameter Neuromonitoring System2026-04-10
K250285 — NEUROVENT-P (092946-003) +15 more2025-08-29
K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)2024-07-18
K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)2024-02-04
K201989 — B4C System2021-10-08

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K121573

K-number listed on FDA's recall record

Z-1618-2015 — The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).Class II·Terminated·Integra LifeSciences Corp.·20150414
Z-1619-2015 — The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.Class II·Terminated·Integra LifeSciences Corp.·20150414
Z-1620-2015 — The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.Class II·Terminated·Integra LifeSciences Corp.·20150414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121573.

Data sourced from openFDA. This site is unofficial and independent of the FDA.