Cleared Traditional

K780307 - CARDIAC MINIGRAPH

K780307 is an FDA 510(k) clearance for CARDIAC MINIGRAPH, manufactured by Arco Medical Products Co.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K780307 · Arco Medical Products Co. · Cardiovascular device
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May 1978
Decision
87d
Days
Class 2
Risk

K780307 is an FDA 510(k) clearance for the CARDIAC MINIGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 87 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 Arco Medical Products Co. devices

FDA 510(k) Submission Details - K780307

510(k) Number K780307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date May 19, 1978
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 305
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K780307.
QUINTON MODEL 530X ECG DATA CART
K790739 · Quinton, Inc. · Apr 1979
ELECTROCARDIOGRAPH, EK-9
K790114 · Burdick Corp. · Feb 1979
MONITOR/MINI SCOPE
K781679 · Ipco Corp. · Dec 1978
STRESS TEST SYSTEM
K780166 · Quinton, Inc. · Feb 1978
EK-670
K780138 · Burdick Corp. · Feb 1978
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977