Cleared Traditional

K153654 - Sentry WEB SmartInterp

K153654 is an FDA 510(k) clearance for Sentry WEB SmartInterp, manufactured by Carefusion Germany 234 GmbH. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 270-day FDA review.

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

FDA 510(k) Submission Details - K153654

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.

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 284
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