Cleared Traditional

K870726 - RT5000 ECHOCARDIOGRAPHY #H4100C/CE

K870726 is an FDA 510(k) clearance for RT5000 ECHOCARDIOGRAPHY #H4100C/CE, manufactured by General Electric Co.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K870726 · General Electric Co. · Cardiovascular device
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Oct 1987
Decision
238d
Days
Class 2
Risk

K870726 is an FDA 510(k) clearance for the RT5000 ECHOCARDIOGRAPHY #H4100C/CE. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Co. devices

FDA 510(k) Submission Details - K870726

510(k) Number K870726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1987
Decision Date October 20, 1987
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K870726.
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
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K871416 · Acuson Computed Sonography · Sep 1987
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5 MHZ TRANSDUCER
K872074 · Sonicaid, Inc. · Aug 1987