Cleared Traditional

K881772 - SENSOCOR(TM) R-TEST 240 XL

K881772 is the FDA 510(k) clearance for SENSOCOR(TM) R-TEST 240 XL by Sensormedix, Inc.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K881772 · Sensormedix, Inc. · Cardiovascular device
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Nov 1988
Decision
197d
Days
Class 2
Risk

K881772 is an FDA 510(k) clearance for the SENSOCOR(TM) R-TEST 240 XL. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Sensormedix, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on November 9, 1988 after a review of 197 days - an extended review 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: 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 Sensormedix, Inc. devices

Submission Details

510(k) Number K881772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date November 09, 1988
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
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 93
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