Cleared Traditional

K152881 - SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

K152881 is an FDA 510(k) clearance for SENTINEL CARDIOLOGY INFORMATION MANAGEM..., manufactured by Spacelabs Healthcare, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K152881 · Spacelabs Healthcare, Ltd. · Cardiovascular device
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Apr 2016
Decision
184d
Days
Class 2
Risk

K152881 is an FDA 510(k) clearance for the SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Spacelabs Healthcare, Ltd. (Hertford, GB). The FDA issued a Cleared decision on April 1, 2016 after a review of 184 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 Spacelabs Healthcare, Ltd. devices

FDA 510(k) Submission Details - K152881

510(k) Number K152881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date April 01, 2016
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 Consultant

Speed TO Market, Inc.
THOMAS KROENKE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 391
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