Cleared Traditional

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS (K844391) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844391 · Ams Medical, Inc. · Cardiovascular device
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Jan 1985
Decision
55d
Days
Class 2
Risk

K844391 is an FDA 510(k) clearance for the NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Ams Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ams Medical, Inc. devices

Submission Details

510(k) Number K844391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 07, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K844391.
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