Cleared Traditional

K904606 - MODEL 405

K904606 is the FDA 510(k) clearance for MODEL 405 by Ivy Biomedical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K904606 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
142d
Days
Class 2
Risk

K904606 is an FDA 510(k) clearance for the MODEL 405. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 1, 1991 after a review of 142 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 Ivy Biomedical Systems, Inc. devices

Submission Details

510(k) Number K904606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date March 01, 1991
Days to Decision 142 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 125d · This submission: 142d
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 248
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K904606.
HL-300 RECEIVER MODULE
K915879 · Fukuda Denshi USA, Inc. · Jan 1992
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · Fukuda Denshi USA, Inc. · Aug 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990