# K981720: IQ System

- Pathway: 510(k) (Traditional)
- Applicant: Renaissance Technology, Inc.
- Decided: Feb 8, 1999 after 279 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
77 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042113: Zoe Fluid Status Monitor (2004), 76 descendants of its own
- K083287: Avivo Mobile Patient Management System (2009), 57 descendants of its own
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own

## Indications for use
As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications. The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.

Source page: https://510kreport.com/device/K981720
Methodology: https://510kreport.com/methodology