Cleared Traditional

K130207 - SPACELABS HEALTHCARE CARDIOEXPRESS

K130207 is an FDA 510(k) clearance for SPACELABS HEALTHCARE CARDIOEXPRESS, manufactured by Spacelabs Healthcare, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K130207

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DPS Electrocardiograph

All 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K130207.
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