Cleared Traditional

K954163 - RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER

K954163 is an FDA 510(k) clearance for RETROSPECTIVE II-ELITE ECG MEMORY LOOP ..., manufactured by Cardiac Evaluation Center, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K954163 · Cardiac Evaluation Center, Inc. · Cardiovascular device
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Jul 1996
Decision
310d
Days
Class 2
Risk

K954163 is an FDA 510(k) clearance for the RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Cardiac Evaluation Center, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 11, 1996 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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. Elevated predicate reliance profile. 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 Cardiac Evaluation Center, Inc. devices

FDA 510(k) Submission Details - K954163

510(k) Number K954163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date July 11, 1996
Days to Decision 310 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
185d slower than avg
Panel avg: 125d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 175
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