Cleared Traditional

K955059 - OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER

K955059 is an FDA 510(k) clearance for OLYMPUS COMM. NTWK., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K955059 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
214d
Days
Class 2
Risk

K955059 is an FDA 510(k) clearance for the OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 214 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

FDA 510(k) Submission Details - K955059

510(k) Number K955059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1995
Decision Date June 07, 1996
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K955059.
EAGLE PATIENT MONITOR MODEL 3000/3100
K961139 · Marquette Electronics, Inc. · Aug 1996
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743 · Siemens Medical Solutions USA, Inc. · Jul 1996
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
K952054 · Siemens Medical Solutions USA, Inc. · Jun 1996
SOLAR 9000 ANESTHESIA INFORMATION MONITOR
K954852 · Marquette Electronics, Inc. · May 1996
QUEST EXERCISE STRESS SYSTEM
K952417 · Burdick, Inc. · May 1996
CARDIO PERFECT ST 2001
K935732 · Cardio Control BV · Apr 1996