Cleared Traditional

K855045 - MODEL 535 NEO-TRAK RECORDER

K855045 is an FDA 510(k) clearance for MODEL 535 NEO-TRAK RECORDER, manufactured by Ge Medical Systems Information Technologies. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K855045 · Ge Medical Systems Information Technologies · Cardiovascular device
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May 1986
Decision
150d
Days
Class 1
Risk

K855045 is an FDA 510(k) clearance for the MODEL 535 NEO-TRAK RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on May 16, 1986 after a review of 150 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K855045

510(k) Number K855045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date May 16, 1986
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

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 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K855045.
VSM(R) R2 PAPER CHART RECORDER
K880554 · Physio-Control Corp. · May 1988
MODEL 78576A PAPER CHART RECORDER
K872822 · Hewlett-Packard Co. · Nov 1987
SIREDOC 60 AND SIREDOC 220
K863331 · Siemens Medical Solutions USA, Inc. · Oct 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