Cleared Traditional

K991786 - MARS UNITY WORKSTATION WITH HEART RATE ...

K991786 is the FDA 510(k) clearance for MARS UNITY WORKSTATION WITH HEART RATE ... by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K991786 · General Electric Medical Systems Information Techn · Cardiovascular device
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Nov 1999
Decision
177d
Days
Class 2
Risk

K991786 is an FDA 510(k) clearance for the MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

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Submission Details

510(k) Number K991786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date November 18, 1999
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K991786.
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K974746 · Hewlett-Packard Co. · Mar 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · Alexander Mfg. Co. · Oct 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · Marquette Electronics, Inc. · Sep 1997