Cleared Traditional

K863042 - SIRECUST 888/888R NON-INVASIVE BLOOD PR...

K863042 is the FDA 510(k) clearance for SIRECUST 888/888R NON-INVASIVE BLOOD PR... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K863042 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Jan 1987
Decision
155d
Days
Class 2
Risk

K863042 is an FDA 510(k) clearance for the SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on January 14, 1987 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K863042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date January 14, 1987
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.

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.

Regulatory Peers - DSK Computer, Blood-pressure

All 31
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K863042.
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K874339 · A&D Engineering, Inc. · Dec 1987
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720 · A&D Engineering, Inc. · Jul 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · A&D Engineering, Inc. · Jun 1987
MODIFIED CARDIOCAP MONITOR
K862455 · Datex Division Instrumentarium Corp. · Sep 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985