Cleared Traditional

K905856 - MODEL 556 MONITOR

K905856 is an FDA 510(k) clearance for MODEL 556 MONITOR, 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 88-day FDA review.

K905856 · Ge Medical Systems Information Technologies · Cardiovascular device
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Jan 1991
Decision
88d
Days
Class 1
Risk

K905856 is an FDA 510(k) clearance for the MODEL 556 MONITOR. 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 January 11, 1991 after a review of 88 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K905856

510(k) Number K905856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date January 11, 1991
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K905856.
COLORADO COLOR IMAGING RECORDER
K902230 · Honeywell, Inc. · Jun 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · S & W Medico Teknik · Jan 1990
CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
WS 800R THERMAL ARRAY RECORDER
K881831 · Nihon Kohden America, Inc. · Jul 1988
LIFESTAT 1600 PRINTER
K881346 · Physio-Control Corp. · Jun 1988