Cleared Traditional

K933021 - MODEL T131 MEMORY TRANSMITTER

K933021 is an FDA 510(k) clearance for MODEL T131 MEMORY TRANSMITTER, manufactured by Biometric Products, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K933021 · Biometric Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
349d
Days
Class 2
Risk

K933021 is an FDA 510(k) clearance for the MODEL T131 MEMORY TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Biometric Products, Inc. (Miami, US). The FDA issued a Cleared decision on June 6, 1994 after a review of 349 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 Biometric Products, Inc. devices

FDA 510(k) Submission Details - K933021

510(k) Number K933021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date June 06, 1994
Days to Decision 349 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 125d · This submission: 349d
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 194
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K933021.
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704 · Card Guard Scientific Survival , Ltd. · Dec 1994
PRINCE
K935586 · Instromedix, Inc. · Nov 1994
CARD GUARD, MODEL CG-9000
K924486 · Card Guard Scientific Survival , Ltd. · Oct 1994
CARD GUARD MODEL CG-8000
K926515 · Card Guard Scientific Survival , Ltd. · Mar 1994
CARDIOMAGIC SOFTWARE
K925639 · Instromedix, Inc. · Jun 1993
KING OF HEARTS EXPRESS (E.X.) MONITOR
K920984 · Instromedix, Inc. · Oct 1992