Cleared Traditional

K860689 - SPACELABS P.C. CARDIAC OUTPUT/PRESSURE ...

K860689 is an FDA 510(k) clearance for SPACELABS P.C. CARDIAC OUTPUT/PRESSURE ..., manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K860689 · Spacelabs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K860689

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
Combination Product No
PCCP Authorized No
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.

DSK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DSK Computer, Blood-pressure

All 37
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K860689.
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODIFIED CARDIOCAP MONITOR
K862455 · Datex Division Instrumentarium Corp. · Sep 1986
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · Ivy Biomedical Systems, Inc. · Aug 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985
LME BLOOD PRESSURE MONITOR
K832017 · Litton Medical Electronics · Oct 1983
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982