Cleared Traditional

GRI LASERGRAPH(TM) ECG PAPER (K902586) - FDA 510(k) Clearance

Class I Cardiovascular device.

K902586 · Gri Medical Products, Inc. · Cardiovascular device
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Jun 1990
Decision
10d
Days
Class 1
Risk

K902586 is an FDA 510(k) clearance for the GRI LASERGRAPH(TM) ECG PAPER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Gri Medical Products, Inc. (Norwalk, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 10 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 Gri Medical Products, Inc. devices

Submission Details

510(k) Number K902586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date June 22, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
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 15
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K902586.
MODEL 556 MONITOR
K905856 · Ge Medical Systems Information Technologies · Jan 1991
WS 800R THERMAL ARRAY RECORDER
K881831 · Nihon Kohden America, Inc. · Jul 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
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