Cleared Traditional

K851625 - SCX-10 SINGLE CHANNEL RECORDER ACCESS. ...

K851625 is the FDA 510(k) clearance for SCX-10 SINGLE CHANNEL RECORDER ACCESS. ... by Eaton Medical Group. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K851625 · Eaton Medical Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
215d
Days
Class 1
Risk

K851625 is an FDA 510(k) clearance for the SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000. 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 November 19, 1985 after a review of 215 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Eaton Medical Group devices

Submission Details

510(k) Number K851625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date November 19, 1985
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
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 K851625.
SIREDOC 60 AND SIREDOC 220
K863331 · Siemens Medical Solutions USA, Inc. · Oct 1986
MODEL 535 NEO-TRAK RECORDER
K855045 · Ge Medical Systems Information Technologies · May 1986
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