Cleared Traditional

K820011 - CARDIOSTRESS

K820011 is an FDA 510(k) clearance for CARDIOSTRESS, manufactured by Instruments For Cardiac Research. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820011 · Instruments For Cardiac Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
17d
Days
Class 2
Risk

K820011 is an FDA 510(k) clearance for the CARDIOSTRESS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Instruments For Cardiac Research (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 17 days - a notably fast clearance cycle.

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: 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 Instruments For Cardiac Research devices

FDA 510(k) Submission Details - K820011

510(k) Number K820011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1982
Decision Date January 22, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 463
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K820011.
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · Birtcher Corp. · Jul 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · Brentwood Instruments, Inc. · Dec 1981
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
FUKUDA DENSHI CARDIMAX FK-12
K813022 · Brentwood Instruments, Inc. · Dec 1981