Cleared Traditional

K213181 - CARESCAPE B650

K213181 is the FDA 510(k) clearance for CARESCAPE B650 by GE Healthcare Finland Oy. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K213181 · GE Healthcare Finland Oy · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
196d
Days
Class 2
Risk

K213181 is an FDA 510(k) clearance for the CARESCAPE B650, E-musb. 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 13, 2022 after a review of 196 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

Submission Details

510(k) Number K213181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date April 13, 2022
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K213181.
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
K221616 · Caf Medical Solutions, Inc. · Aug 2022
Next Generation NetKonnect
K220989 · Nihon Kohden Digital Health Solutions, Inc. · Jul 2022
N Series Patient Monitors
K213799 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2022
Carescape B850, E-musb
K213336 · GE Healthcare Finland Oy · Apr 2022
CARESCAPE B450, E-musb
K213363 · GE Healthcare Finland Oy · Apr 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
K213234 · Ge Medical Systems Information Technologies, Inc. · Apr 2022