# K172182: QUANTIEN Measurement System

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical (Now Part of the Abbott Medical)
- Decided: Aug 18, 2017 after 30 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: 7 generations back to K003122 (2001). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123984: Quantien Measurement System, Radi Medical Systems AB (2013) Summary page 4.

## Most influential descendants
- K183099: QUANTIEN Measurement System (2019), 3 descendants of its own
- 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
QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. QUANTIEN Measurement System is intended for use in 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/K172182
Methodology: https://510kreport.com/methodology