Cleared Traditional

QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 (K011339) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011339 · Spacelabs Burdick, Inc. · Cardiovascular device
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Aug 2001
Decision
110d
Days
Class 2
Risk

K011339 is an FDA 510(k) clearance for the QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs Burdick, Inc. (South West Ranches, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 110 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.

View all Spacelabs Burdick, Inc. devices

Submission Details

510(k) Number K011339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date August 20, 2001
Days to Decision 110 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K011339.
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
K071655 · Medtronic, Inc. · Nov 2007
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K024213 · Siemens Medical Solutions USA, Inc. · Mar 2004
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
K031433 · Siemens Medical Solutions USA, Inc. · Aug 2003
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · Siemens Medical Solutions USA, Inc. · Aug 2001
ORG-9200A
K002068 · Nihon Kohden America, Inc. · Feb 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · Quinton, Inc. · Jan 2001