Cleared Traditional

K223812 - Sensis Vibe (VD15)

K223812 is an FDA 510(k) clearance for Sensis Vibe (VD15), manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K223812 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
269d
Days
Class 2
Risk

K223812 is an FDA 510(k) clearance for the Sensis Vibe (VD15). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 269 days - an extended review cycle.

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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K223812

510(k) Number K223812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2022
Decision Date September 15, 2023
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
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 361
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K223812.
HemoSphere Alta Advanced Monitoring Platform
K232294 · Edwards Lifesciences, LLC · Oct 2023
Volta AF-Xplorer
K232616 · Volta Medical · Sep 2023
AVVIGO'+ Multi-Modality Guidance System
K230884 · Boston Scientific Corporation · Sep 2023
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
K231207 · Biosense Webster, Inc. · Sep 2023
Smart Wedge algorithm
K230579 · Edwards Lifesciences, LLC · Aug 2023
EnSite™ X EP System
K231415 · Abbott Medical · Aug 2023