Cleared Traditional

Sentry WEB SmartInterp (K153654) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153654 · Carefusion Germany 234 GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
270d
Days
Class 2
Risk

K153654 is an FDA 510(k) clearance for the Sentry WEB SmartInterp. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Carefusion Germany 234 GmbH (Hoechber, DE). The FDA issued a Cleared decision on September 16, 2016 after a review of 270 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 Carefusion Germany 234 GmbH devices

Submission Details

510(k) Number K153654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date September 16, 2016
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 207
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K153654.
MediGuide Technology System
K162643 · St Jude Medical · Dec 2016
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
K160187 · St Jude Medical · Oct 2016
EnSite Velocity Surface Electrode Kit
K160186 · St Jude Medical · Oct 2016
Holter System
K151787 · Edan Instruments, Inc. · Jan 2016
WorkMate Claris System, WorkMate Claris System Display Plus
K151911 · St Jude Medical · Oct 2015
iLab Polaris Multi-Modality Guidance System
K151613 · Boston Scientific Corporation · Oct 2015