Cleared Traditional

EK10 ELECTROCARDIOGRAPH (K870880) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870880 · Burdick Corp. · Cardiovascular device
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Apr 1987
Decision
36d
Days
Class 2
Risk

K870880 is an FDA 510(k) clearance for the EK10 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on April 9, 1987 after a review of 36 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 Burdick Corp. devices

Submission Details

510(k) Number K870880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1987
Decision Date April 09, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K870880.
OEC-7102 ECG/NIBP MONITOR
K882254 · Nihon Kohden America, Inc. · Nov 1988
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
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