Cleared Traditional

K832888 - ECG INTERFERENCE FILTER TF-03

K832888 is the FDA 510(k) clearance for ECG INTERFERENCE FILTER TF-03 by La Jolla Technology, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K832888 · La Jolla Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832888.
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
MORTARA INSTRUMENT #101
K832050 · Mortara Instrument, Inc. · Dec 1983
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983