Cleared Traditional

K780138 - EK-670

K780138 is an FDA 510(k) clearance for EK-670, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K780138 · Burdick Corp. · Cardiovascular device
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Feb 1978
Decision
23d
Days
Class 2
Risk

K780138 is an FDA 510(k) clearance for the EK-670. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1978 after a review of 23 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

FDA 510(k) Submission Details - K780138

510(k) Number K780138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1978
Decision Date February 17, 1978
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 277
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K780138.
QUINTON MODEL 530X ECG DATA CART
K790739 · Quinton, Inc. · Apr 1979
ELECTROCARDIOGRAPH, EK-9
K790114 · Burdick Corp. · Feb 1979
STRESS TEST SYSTEM
K780166 · Quinton, Inc. · Feb 1978
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · General Electric Co. · May 1977
SIMULATOR, 10 LEAD ECG
K761023 · Birtcher Corp. · Jan 1977