Cleared Traditional

K260693 - VicorderCS (VCS-SYS-1100)

K260693 is an FDA 510(k) clearance for VicorderCS (VCS-SYS-1100), manufactured by 80 Beats Medical GmbH. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K260693 · 80 Beats Medical GmbH · Cardiovascular device
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Jun 2026
Decision
105d
Days
Class 2
Risk

K260693 is an FDA 510(k) clearance for the VicorderCS (VCS-SYS-1100). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by 80 Beats Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on June 16, 2026 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 80 Beats Medical GmbH devices

FDA 510(k) Submission Details - K260693

510(k) Number K260693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2026
Decision Date June 16, 2026
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 567
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