# K220243: Ultiri Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Apr 30, 2022 after 92 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: 11 generations back to K934139 (1995). 64 ancestors in all.
No later device cites it as a predicate yet.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210458: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System, Abbott Medical (2021) Summary page 4.
- K183099: QUANTIEN Measurement System, St. Jude Medical (Now Abbott Medical) (2019) Summary page 4.

## Indications for use
The Ultreon™ Software for Ultiri™ Measurement System is intended to be used only with compatible Ultiri™ Measurement Systems. The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated. The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.

Source page: https://510kreport.com/device/K220243
Methodology: https://510kreport.com/methodology