Cleared Traditional

K942058 - SPACELABS MEDICAL ECG MODULE (MODEL 90492)

K942058 is an FDA 510(k) clearance for SPACELABS MEDICAL ECG MODULE (MODEL 90492), 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 383-day FDA review.

K942058 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
383d
Days
Class 2
Risk

K942058 is an FDA 510(k) clearance for the SPACELABS MEDICAL ECG MODULE (MODEL 90492). 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 May 17, 1995 after a review of 383 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K942058

510(k) Number K942058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date May 17, 1995
Days to Decision 383 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
258d slower than avg
Panel avg: 125d · This submission: 383d
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 K942058.
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306 · Siemens Medical Solutions USA, Inc. · Jun 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
K935877 · Nihon Kohden America, Inc. · May 1995
BSM-8800A BEDSIDE MONITOR
K944422 · Nihon Kohden America, Inc. · May 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · Siemens Medical Solutions USA, Inc. · May 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · Siemens Medical Solutions USA, Inc. · Apr 1995
SC 6000/ SC 6000P/ R50
K944350 · Siemens Medical Solutions USA, Inc. · Apr 1995