Cleared Special

K121480 - ARIATELE TELEMETRY TRANSMITTER (96281)

K121480 is an FDA 510(k) clearance for ARIATELE TELEMETRY TRANSMITTER (96281), manufactured by Spacelabs Healthcare. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 19-day FDA review.

K121480 · Spacelabs Healthcare · Cardiovascular device
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Jun 2012
Decision
19d
Days
Class 2
Risk

K121480 is an FDA 510(k) clearance for the ARIATELE TELEMETRY TRANSMITTER (96281). 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 June 6, 2012 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spacelabs Healthcare devices

FDA 510(k) Submission Details - K121480

510(k) Number K121480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date June 06, 2012
Days to Decision 19 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 332
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K121480.
INTELLIVUE PATIENT MONITOR
K122439 · Philips Medizin Systeme Boeblingen GmbH · Aug 2012
INTELLIVUE PATIENT MONITOR
K120366 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jul 2012
ZOLL PROPAQ XM
K121367 · ZOLL Medical Corporation · Jun 2012
PATIENT MONITOR
K120173 · Edan Instruments, Inc. · May 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · Spacelabs Medical, Inc. · Mar 2012
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
K113441 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 2012