Cleared Traditional

K780404 - ECG MONITORING SYSTEM,

K780404 is an FDA 510(k) clearance for ECG MONITORING SYSTEM, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K780404 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1978
Decision
15d
Days
Class 2
Risk

K780404 is an FDA 510(k) clearance for the ECG MONITORING SYSTEM,. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Quinton, Inc.. The FDA issued a Cleared decision on March 28, 1978 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quinton, Inc. devices

FDA 510(k) Submission Details - K780404

510(k) Number K780404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1978
Decision Date March 28, 1978
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 220
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K780404.
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979
CARDIAC MINISCOPE & MINIGRAPH
K780297 · Arco Medical Products Co. · May 1978
CSS-60 DIGITAL HEART RATE METER
K780702 · Burdick Corp. · May 1978
MONITOR, CARDIAC, BEDSIDE
K772332 · Telectronics, Inc. · Feb 1978
ACUTE CARDIAC CARE SYSTEM
K772006 · Physio-Control Corp. · Nov 1977
PHYSIOLOGICAL MONITOR MODEL 871
K772056 · Datascope Corp. · Nov 1977