Cleared Traditional

K981720 - IQ SYSTEM

K981720 is an FDA 510(k) clearance for IQ SYSTEM, manufactured by Renaissance Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K981720 · Renaissance Technology, Inc. · Cardiovascular device
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Feb 1999
Decision
279d
Days
Class 2
Risk

K981720 is an FDA 510(k) clearance for the IQ SYSTEM. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Renaissance Technology, Inc. (Newtown, US). The FDA issued a Cleared decision on February 8, 1999 after a review of 279 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Renaissance Technology, Inc. devices

FDA 510(k) Submission Details - K981720

510(k) Number K981720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1998
Decision Date February 08, 1999
Days to Decision 279 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 125d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 27
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K981720.
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
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ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001
BIOZ.COM SYSTEM
K974725 · Cardiodynamics International Corp. · Mar 1998
PERCUPUMP II WITH EDA
K974621 · E-Z-Em, Inc. · Jan 1998
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · Cardiodynamics International Corp. · Sep 1997