Cleared Traditional

K201881 - CoroFlow Cardiovascular System

K201881 is an FDA 510(k) clearance for CoroFlow Cardiovascular System, manufactured by Coroventis Research AB. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K201881 · Coroventis Research AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
129d
Days
Class 2
Risk

K201881 is an FDA 510(k) clearance for the CoroFlow Cardiovascular System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Coroventis Research AB (Uppsala, SE). The FDA issued a Cleared decision on November 13, 2020 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Coroventis Research AB devices

FDA 510(k) Submission Details - K201881

510(k) Number K201881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2020
Decision Date November 13, 2020
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 269
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K201881.
CARTO® 3 EP Navigation System with Signal Processing Unit
K200484 · Biosense Webster, Inc. · Nov 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
K202066 · Abbott Medical · Nov 2020
Cordiana Dx16
K201060 · Cordiana Medical Informatics AG · Nov 2020
KardiaAI
K201985 · AliveCor, Inc. · Nov 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · Edwards Lifesiences, LLC · Oct 2020
VX1
K201298 · Volta Medical · Sep 2020