Cleared Traditional

SPACELABS HEALTHCARE CARDIOEXPRESS (K130207) - FDA 510(k) Clearance

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

K130207 · Spacelabs Healthcare, Ltd. · Cardiovascular device
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Jul 2013
Decision
176d
Days
Class 2
Risk

K130207 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE CARDIOEXPRESS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on July 23, 2013 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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

Submission Details

510(k) Number K130207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2013
Decision Date July 23, 2013
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.

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All 123
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