Cleared Traditional

K823529 - FULL-DISCLOSURE AMBULATORY ECG SYSTEM

K823529 is the FDA 510(k) clearance for FULL-DISCLOSURE AMBULATORY ECG SYSTEM by Clinical Data, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K823529 · Clinical Data, Inc. · Cardiovascular device
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Dec 1982
Decision
22d
Days
Class 2
Risk

K823529 is an FDA 510(k) clearance for the FULL-DISCLOSURE AMBULATORY ECG SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 22 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K823529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date December 15, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 177
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K823529.
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · Honeywell, Inc. · May 1983
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
COSMOS
K823220 · Nihon Kohden America, Inc. · Nov 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982