Cleared Traditional

MEMORY LOOP TRANSMITTER #121 (K832951) - FDA 510(k) Clearance

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

K832951 · Biometric Products, Inc. · Cardiovascular device
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Feb 1984
Decision
168d
Days
Class 2
Risk

K832951 is an FDA 510(k) clearance for the MEMORY LOOP TRANSMITTER #121. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Biometric Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 168 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 Biometric Products, Inc. devices

Submission Details

510(k) Number K832951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date February 17, 1984
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
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 K832951.
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · Hewlett-Packard Co. · Dec 1984
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · Medtronic Vascular · Nov 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · Intermedics, Inc. · Jul 1982
MODEL 535-03 TRACE A PACE
K812755 · Intermedics, Inc. · Nov 1981