Cleared Abbreviated

QUINTON Q-TE (K041607) - FDA 510(k) Clearance

Also marketed or referenced as:
RMS

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K041607 · Quinton Cardiology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
31d
Days
Class 2
Risk

K041607 is an FDA 510(k) clearance for the QUINTON Q-TE. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Quinton Cardiology, Inc. (Bothell, US). The FDA issued a Cleared decision on July 16, 2004 after a review of 31 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Quinton Cardiology, Inc. devices

Submission Details

510(k) Number K041607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date July 16, 2004
Days to Decision 31 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Standards-based clearance path.

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 122
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K041607.
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
K051217 · Ge Healthcare · Feb 2006
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS
K051400 · Ge Healthcare · Jan 2006
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
K052756 · Ge Healthcare · Nov 2005
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395 · Nihon Kohden America, Inc. · Jun 2004
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340 · Siemens Medical Solutions USA, Inc. · Nov 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · Siemens Medical Solutions USA, Inc. · Jun 2003