Cleared Traditional

K141156 - SPACELABS HEALTHCARE TELEMETRY RECEIVER

K141156 is an FDA 510(k) clearance for SPACELABS HEALTHCARE TELEMETRY RECEIVER, manufactured by Spacelabs Healthcare. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K141156 · Spacelabs Healthcare · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
127d
Days
Class 2
Risk

K141156 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE TELEMETRY RECEIVER. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on September 9, 2014 after a review of 127 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.

FDA 510(k) Submission Details - K141156

510(k) Number K141156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2014
Decision Date September 09, 2014
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 421
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K141156.
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
K143195 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Dec 2014
MORTARA MONITORING WAVEFORM VIEWER
K141811 · Mortara Instrument, Inc. · Nov 2014
Panorama Patient Monitoring Network
K142601 · Shenzhen Mindray Bio-Medical Electronics Co. · Nov 2014
SAAD PATIENT MONITOR (SPM)
K133222 · Hanin Medical Services Co., Ltd. · Aug 2014
PASSPORT SERIES PATIENT MONITORS
K132662 · Shenzhen Mindray Biomedical Electronics Co., Ltd. · Aug 2014
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
K141015 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · May 2014