Cleared Traditional

K260343 - Carescape Canvas 1000

Also marketed or referenced as:
Carescape Canvas Smart Display

K260343 is an FDA 510(k) clearance for Carescape Canvas 1000, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K260343 · GE Healthcare Finland Oy · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
207d
Days
Class 2
Risk

K260343 is an FDA 510(k) clearance for the Carescape Canvas 1000. 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 August 28, 2026 after a review of 207 days - an extended review cycle.

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

FDA 510(k) Submission Details - K260343

510(k) Number K260343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date August 28, 2026
Days to Decision 207 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
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K260343.
Infinity® Acute Care System (IACS) – VG8.1
K260579 · Draeger Medical Systems, Inc. · Aug 2026
Telemetry Monitor (iT30, iT50)
K251508 · Edan Instruments, Inc. · Aug 2026
Radius VSM and Accessories
K254209 · Masimo Corporation · Jun 2026
M12 Telemetry System
K252840 · Global Instrumentation, LLC · May 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
K260098 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2026
Vista CMS
K250349 · Shanghai Draeger Medical Instrument Co., Ltd. · Apr 2026