Cleared Traditional

K872822 - MODEL 78576A PAPER CHART RECORDER

K872822 is the FDA 510(k) clearance for MODEL 78576A PAPER CHART RECORDER by Hewlett-Packard Co.. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K872822 · Hewlett-Packard Co. · Cardiovascular device
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Nov 1987
Decision
110d
Days
Class 1
Risk

K872822 is an FDA 510(k) clearance for the MODEL 78576A PAPER CHART RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 110 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K872822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1987
Decision Date November 04, 1987
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K872822.
LIFESTAT 1600 PRINTER
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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