# K252238: CoroFlow Cardiovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Coroventis Research AB
- Decided: Oct 24, 2025 after 99 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: 12 generations back to K934139 (1995). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201881: CoroFlow Cardiovascular System, Coroventis Research AB (2020) Summary page 5.
- K183099: QUANTIEN Measurement System, St. Jude Medical (Now Abbott Medical) (2019) Summary page 5.
- K092105: Radianalyzer Xpress, Radi Medical Systems AB (2009) Summary page 5.

## Indications for use
CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases. CoroFlow 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 measuring devices.

Source page: https://510kreport.com/device/K252238
Methodology: https://510kreport.com/methodology