Cleared Traditional

K870926 - C150-P ECG CABLES

K870926 is an FDA 510(k) clearance for C150-P ECG CABLES, manufactured by Desco Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K870926 · Desco Industries, Inc. · Cardiovascular device
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May 1987
Decision
73d
Days
Class 2
Risk

K870926 is an FDA 510(k) clearance for the C150-P ECG CABLES. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Desco Industries, Inc. (Walnut, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 73 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 Desco Industries, Inc. devices

FDA 510(k) Submission Details - K870926

510(k) Number K870926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1987
Decision Date May 21, 1987
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
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 433
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K870926.
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K864843 · Mennen Medical, Inc. · Mar 1987