Cleared Traditional

K896772 - EKG

K896772 is the FDA 510(k) clearance for EKG by Cambridge Medical Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896772 · Cambridge Medical Instruments, Inc. · Cardiovascular device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896772 is an FDA 510(k) clearance for the EKG, ECG KENZ, ECG 303. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Medical Instruments, Inc. (Ossining, US). The FDA issued a Cleared decision on February 26, 1990 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 Cambridge Medical Instruments, Inc. devices

Submission Details

510(k) Number K896772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date February 26, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K896772.
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K896417 · Kontron Instruments, Inc. · Dec 1989