Cleared Traditional

K993757 - SOLAR 7/8000

K993757 is an FDA 510(k) clearance for SOLAR 7/8000, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K993757 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
139d
Days
Class 2
Risk

K993757 is an FDA 510(k) clearance for the SOLAR 7/8000. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 139 days - within the typical 510(k) review window.

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 General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K993757

510(k) Number K993757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1999
Decision Date March 23, 2000
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 302
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K993757.
APEXPRO TELEMETRY SYSTEM
K000779 · General Electric Medical Systems Information Techn · May 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
K001057 · Agilent Technologies, Inc. · May 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746 · Fukuda Denshi USA, Inc. · Apr 2000
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908 · Quinton, Inc. · Mar 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
K993383 · Hewlett-Packard GmbH · Feb 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · Datascope Corp. · Jan 2000