# K183099: QUANTIEN Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical (Now Abbott Medical)
- Decided: Feb 28, 2019 after 113 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: 10 generations back to K934139 (1995). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172182: QUANTIEN Measurement System, St. Jude Medical (Now Part of the Abbott Medical) (2017) Summary page 4.
- K133323: Volcano Ifr Modality, Volcano Corporation (2014) Summary page 4.

## Most influential descendants
- K201881: CoroFlow Cardiovascular System (2020), 1 descendant of its own
- K252238: CoroFlow Cardiovascular System (2025), 0 descendants of its own
- K220243: Ultiri Measurement System (2022), 0 descendants of its own

## Indications for use
The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

Source page: https://510kreport.com/device/K183099
Methodology: https://510kreport.com/methodology