Cleared Traditional

SERIES 602 CKGTM RECORDER (K800851) - FDA 510(k) Clearance

Class I Cardiovascular device.

K800851 · Cardio Kinetics, Inc. · Cardiovascular device
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Apr 1980
Decision
9d
Days
Class 1
Risk

K800851 is an FDA 510(k) clearance for the SERIES 602 CKGTM RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Cardio Kinetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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 Cardio Kinetics, Inc. devices

Submission Details

510(k) Number K800851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1980
Decision Date April 24, 1980
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 16
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K800851.
SIREDOC, PAPER CHART RECORDER
K850146 · Siemens Medical Solutions USA, Inc. · Feb 1985
DUAL CHANNEL RECORDER #78574A
K830315 · Hewlett-Packard Co. · Mar 1983
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · Ge Medical Systems Information Technologies · Nov 1982
ECG PAPER, 3 CHANNEL
K780597 · Abco Dealers, Inc. · Jun 1978
PHYSIOLOGICAL RECORDER MODEL 721A
K772052 · Datascope Corp. · Nov 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054 · Datascope Corp. · Nov 1977