Cleared Traditional

K851633 - CC-100 CLOCK/CALANDER MODULE ACCESS. FO...

K851633 is the FDA 510(k) clearance for CC-100 CLOCK/CALANDER MODULE ACCESS. FO... by Eaton Medical Group. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K851633 · Eaton Medical Group · Cardiovascular device
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Jun 1985
Decision
69d
Days
Class 2
Risk

K851633 is an FDA 510(k) clearance for the CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Eaton Medical Group (Eaton, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 69 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 Eaton Medical Group devices

Submission Details

510(k) Number K851633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date June 26, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
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 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K851633.
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985