Cleared Traditional

K042981 - HYPERQ SYSTEM

K042981 is an FDA 510(k) clearance for HYPERQ SYSTEM, manufactured by Biological Signal Processing, Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K042981 · Biological Signal Processing, Ltd. · Cardiovascular device
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Mar 2005
Decision
132d
Days
Class 2
Risk

K042981 is an FDA 510(k) clearance for the HYPERQ SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Biological Signal Processing, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on March 10, 2005 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Biological Signal Processing, Ltd. devices

FDA 510(k) Submission Details - K042981

510(k) Number K042981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date March 10, 2005
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 179
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K042981.
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UNITY NETWORK ID
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STAR 50 MONITORING SYSTEM
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PLANET 50 MONITORING SYSTEM
K043370 · Larsen & Toubro Limited · Feb 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
STELLAR 404 MONITORING SYSTEM
K042560 · Larsen & Toubro Limited · Oct 2004