Cleared Traditional

K945429 - SPACELABS MEDICAL EXPANSION MODULE (MOD...

K945429 is an FDA 510(k) clearance for SPACELABS MEDICAL EXPANSION MODULE (MOD..., 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 281-day FDA review.

K945429 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
281d
Days
Class 2
Risk

K945429 is an FDA 510(k) clearance for the SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352). 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 August 15, 1995 after a review of 281 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 - K945429

510(k) Number K945429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date August 15, 1995
Days to Decision 281 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
156d slower than avg
Panel avg: 125d · This submission: 281d
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 K945429.
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
K951371 · Siemens Medical Solutions USA, Inc. · Oct 1995
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821 · Hewlett-Packard Co. · Oct 1995
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
K952885 · Spacelabs Medical, Inc. · Sep 1995
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