Cleared Traditional

K860689 - SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE (FDA 510(k) Clearance)

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

K860689 · Spacelabs, Inc. · Cardiovascular device
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Jul 1986
Decision
155d
Days
Class 2
Risk

K860689 is an FDA 510(k) clearance for the SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on July 30, 1986 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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, Inc. devices

Submission Details

510(k) Number K860689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date July 30, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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.