Cleared Traditional

K850365 - RECORDING ACCESSORY FOR G-2000 EKG MACH...

K850365 is the FDA 510(k) clearance for RECORDING ACCESSORY FOR G-2000 EKG MACH... by Eaton Medical Group. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K850365 · Eaton Medical Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
69d
Days
Class 1
Risk

K850365 is an FDA 510(k) clearance for the RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Eaton Medical Group (Eaton, US). The FDA issued a Cleared decision on April 9, 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 870.2810 - 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 Eaton Medical Group devices

Submission Details

510(k) Number K850365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date April 09, 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.

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 51
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K850365.
LONG TERM RECORDER RAG 1200
K854866 · Nihon Kohden America, Inc. · Apr 1986
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487 · Fukuda Denshi USA, Inc. · Sep 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274 · Ohmeda Medical · May 1985
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
K850487 · Novametrix Medical Systems, Inc. · Mar 1985
SIREDOC, PAPER CHART RECORDER
K850146 · Siemens Medical Solutions USA, Inc. · Feb 1985
THERMAL GRAYSCALE RF-100
K843836 · Fukuda Denshi USA, Inc. · Oct 1984