Cleared Traditional

K781115 - PRINTER

K781115 is the FDA 510(k) clearance for PRINTER by Output, Inc.. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K781115 · Output, Inc. · Cardiovascular device
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Oct 1978
Decision
95d
Days
Class 1
Risk

K781115 is an FDA 510(k) clearance for the PRINTER, DIGITAL. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Output, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1978 after a review of 95 days - within the typical 510(k) review window.

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 Output, Inc. devices

Submission Details

510(k) Number K781115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date October 06, 1978
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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 33
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K781115.
CENTRAL STATION CONTROLLER AC100/CE100
K810169 · Honeywell, Inc. · Feb 1981
ADVANCEMED EXAMINER
K803225 · American Edwards Laboratories · Jan 1981
LS-8 VISICORDER
K790825 · Honeywell, Inc. · May 1979
ECG PAPER, 3 CHANNEL
K780597 · Abco Dealers, Inc. · Jun 1978
DRY SILVER PROCESSOR MODEL 1226
K780640 · Honeywell, Inc. · Apr 1978
RECORDER, PAPER, ECG
K772333 · Telectronics, Inc. · Feb 1978