Cleared Traditional

K884106 - SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL

K884106 is the FDA 510(k) clearance for SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K884106 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Mar 1989
Decision
158d
Days
Class 2
Risk

K884106 is an FDA 510(k) clearance for the SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 6, 1989 after a review of 158 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K884106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date March 06, 1989
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 225
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K884106.
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · Mennen Medical, Inc. · Apr 1989
MEDILOG EDITOR
K890338 · Oxford Medilog, Inc. · Apr 1989
SUPERMON ARRHYTHMIA MODULE 7270
K882206 · Kontron Instruments, Inc. · Apr 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · Del Mar Avionics · Feb 1989
E550 ELECTROCARDIOGRAPH
K883440 · Burdick Corp. · Jan 1989
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988