Cleared Traditional

K952912 - SPACELABS MEDICAL INTEGRATED MULTI-PARA...

K952912 is an FDA 510(k) clearance for SPACELABS MEDICAL INTEGRATED MULTI-PARA..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 646-day FDA review.

K952912 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
646d
Days
Class 2
Risk

K952912 is an FDA 510(k) clearance for the SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Redmond, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 646 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Spacelabs Medical, Inc. devices

FDA 510(k) Submission Details - K952912

510(k) Number K952912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date April 02, 1997
Days to Decision 646 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
521d slower than avg
Panel avg: 125d · This submission: 646d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K952912.
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · Hewlett-Packard Co. · May 1997
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
K964187 · Fukuda Denshi USA, Inc. · May 1997
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
K962970 · Spacelabs Medical, Inc. · Mar 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057 · Fukuda Denshi USA, Inc. · Mar 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827 · Marquette Electronics, Inc. · Feb 1997