Cleared Traditional

K780356 - OUTPUT DIGITAL DISPLAY MODULE

K780356 is the FDA 510(k) clearance for OUTPUT DIGITAL DISPLAY MODULE by Output, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K780356 · Output, Inc. · Cardiovascular device
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May 1978
Decision
86d
Days
Class 2
Risk

K780356 is an FDA 510(k) clearance for the OUTPUT DIGITAL DISPLAY MODULE, MODEL 401. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Output, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1978 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Output, Inc. devices

Submission Details

510(k) Number K780356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1978
Decision Date May 31, 1978
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSK Computer, Blood-pressure

All 13
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K780356.
PATIENT MONITOR CM111, 112
K810178 · Honeywell, Inc. · Feb 1981
DUAL TRACE PATIENT MONITOR 116,118,120
K810179 · Honeywell, Inc. · Feb 1981
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
K772334 · Telectronics, Inc. · Feb 1978
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978