Cleared Traditional

K870380 - MODEL 78534C MONITOR/TERMINAL W/OPTIONS...

K870380 is the FDA 510(k) clearance for MODEL 78534C MONITOR/TERMINAL W/OPTIONS... by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K870380 · Hewlett-Packard Co. · Cardiovascular device
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Mar 1987
Decision
41d
Days
Class 2
Risk

K870380 is an FDA 510(k) clearance for the MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on March 11, 1987 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K870380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date March 11, 1987
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K870380.
Q5000 STRESS TEST MONITOR
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K870880 · Burdick Corp. · Apr 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · Mennen Medical, Inc. · Mar 1987
MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)
K864580 · Mortara Instrument, Inc. · Feb 1987
Q700 ELECTROCARDIOGRAPH
K864700 · Quinton, Inc. · Feb 1987
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987