Cleared Traditional

ECG INTERFERENCE FILTER TF-03 (K832888) - FDA 510(k) Clearance

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

K832888 · La Jolla Technology, Inc. · Cardiovascular device
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Jan 1984
Decision
145d
Days
Class 2
Risk

K832888 is an FDA 510(k) clearance for the ECG INTERFERENCE FILTER TF-03. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by La Jolla Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1984 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 La Jolla Technology, Inc. devices

Submission Details

510(k) Number K832888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date January 18, 1984
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 81
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832888.
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · Hewlett-Packard Co. · Jun 1979