Cleared Traditional

K930095 - SPACELABS MEDICAL PATIENT MONITOR

K930095 is an FDA 510(k) clearance for SPACELABS MEDICAL PATIENT MONITOR, 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 238-day FDA review.

K930095 · Spacelabs Medical, Inc. · Cardiovascular device
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Sep 1993
Decision
238d
Days
Class 2
Risk

K930095 is an FDA 510(k) clearance for the SPACELABS MEDICAL PATIENT MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Hamden, US). The FDA issued a Cleared decision on September 3, 1993 after a review of 238 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 - K930095

510(k) Number K930095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1993
Decision Date September 03, 1993
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
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 K930095.
SC 6000/ SC 6000P/ R50
K944350 · Siemens Medical Solutions USA, Inc. · Apr 1995
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
K925510 · Spacelabs Medical, Inc. · Oct 1994
MARQUETTE EAGLE MONITOR
K920790 · Marquette Electronics, Inc. · Apr 1994
CC ARHYTHMIS MONITORING OPTION
K923747 · Hewlett-Packard Co. · Jul 1993
BSM-8800A BEDSIDE MONITOR
K920154 · Nihon Kohden America, Inc. · Dec 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743 · Nihon Kohden America, Inc. · Sep 1992