Cleared Traditional

K962970 - SPACELABS MEDICAL 12-LEAD DIAGNOSTIC EC...

K962970 is an FDA 510(k) clearance for SPACELABS MEDICAL 12-LEAD DIAGNOSTIC EC..., 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 237-day FDA review.

K962970 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
237d
Days
Class 2
Risk

K962970 is an FDA 510(k) clearance for the SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION. 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 March 25, 1997 after a review of 237 days - an extended review cycle.

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: 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 Medical, Inc. devices

FDA 510(k) Submission Details - K962970

510(k) Number K962970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1996
Decision Date March 25, 1997
Days to Decision 237 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
112d slower than avg
Panel avg: 125d · This submission: 237d
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 K962970.
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 INTEGRATED MULTI-PARAMETER MODULE
K952912 · Spacelabs Medical, Inc. · Apr 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
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291 · Siemens Medical Solutions USA, Inc. · Jan 1997