Cleared Traditional

CC-100 (K811016) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811016 · Anthro-Metrics Corp. · Cardiovascular device
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May 1981
Decision
16d
Days
Class 2
Risk

K811016 is an FDA 510(k) clearance for the CC-100. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Anthro-Metrics Corp. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 16 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 Anthro-Metrics Corp. devices

Submission Details

510(k) Number K811016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date May 01, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
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 123
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K811016.
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
MODEL 633A THREE CHANNEL STRESS TEST
K802190 · Quinton, Inc. · Oct 1980