# K021906: Quinton Q-Cath, Model 000460

- Pathway: 510(k) (Abbreviated)
- Applicant: Quinton, Inc.
- Decided: Sep 4, 2002 after 86 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862740 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862740: Quinton Q.Cath, Quinton, Inc. (1986) Summary page 1.

## Indications for use
The device is intended to monitor, analyze, document, and report hemodynamic data acquired during a cardiac catherization procedure. The system contains an acquisition subsystem and an analysis subsystem. The system acquires non-invasive and invasive data parameters. The data is received, displayed, stored, and analyzed in the Q-Cath. The device is to be used on adult and pediatric patients while undergoing a cardiac catherization procedure. Patient demographics, registration, patient assessment, procedure log notes, collected physiological and other Q-Cath data can be exported to an information management system. A Q-Cath remote workstation may be used to access patient files off-line or for the entering of additional patient information or editing of existing patient files. Additionally, the workstation may be used as a means of recording non-invasive vital signs data through the use of qualified third party peripheral monitoring devices. Multiple Q-Cath systems and workstations may be used and connected to a local area network. The Q-Cath system is not intended to be the sole means for monitoring a patient’s status.

Source page: https://510kreport.com/device/K021906
Methodology: https://510kreport.com/methodology