Cleared Traditional

K864978 - APPLISCOPE

K864978 is the FDA 510(k) clearance for APPLISCOPE by Grandcor Medical Systems. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K864978 · Grandcor Medical Systems · Cardiovascular device
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Feb 1987
Decision
59d
Days
Class 2
Risk

K864978 is an FDA 510(k) clearance for the APPLISCOPE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Grandcor Medical Systems (Dayton, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 59 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 Grandcor Medical Systems devices

Submission Details

510(k) Number K864978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date February 19, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 169
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K864978.
Q5000 STRESS TEST MONITOR
K864504 · Quinton, Inc. · Apr 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · Hewlett-Packard Co. · Mar 1987
Q700 ELECTROCARDIOGRAPH
K864700 · Quinton, Inc. · Feb 1987
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · Honeywell, Inc. · Feb 1987
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987