Cleared Traditional

K223531 - CARESCAPE Canvas 1000

K223531 is the FDA 510(k) clearance for CARESCAPE Canvas 1000 by GE Healthcare Finland Oy. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K223531 · GE Healthcare Finland Oy · Cardiovascular device
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Apr 2023
Decision
134d
Days
Class 2
Risk

K223531 is an FDA 510(k) clearance for the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, .... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on April 6, 2023 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Healthcare Finland Oy devices

Submission Details

510(k) Number K223531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2022
Decision Date April 06, 2023
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 274
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K223531.
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
K223574 · Philips Medizin Systeme Boeblingen GmbH · Aug 2023
ARGUS PB-3000
K221056 · Schiller AG · Jul 2023
Radius VSM and Accessories
K223498 · Masimo Corporation · Jun 2023
IntelliVue Patient Monitor MX750 (866471)
K221348 · Philips Medizin Systeme B?blingen GmbH · Feb 2023
Multi-Parameter Patient Monitor
K211619 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2022
Mural Clinical Viewer
K222586 · Ge Medical Systems Information Technologies, Inc. · Dec 2022