Cleared Traditional

K873492 - BSK-1033 TELEMETRY MONITORING CABLE

K873492 is an FDA 510(k) clearance for BSK-1033 TELEMETRY MONITORING CABLE, manufactured by Desco Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K873492 · Desco Industries, Inc. · Cardiovascular device
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Oct 1987
Decision
39d
Days
Class 2
Risk

K873492 is an FDA 510(k) clearance for the BSK-1033 TELEMETRY MONITORING CABLE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Desco Industries, Inc. (Walnut, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 - K873492

510(k) Number K873492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date October 09, 1987
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 79
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K873492.
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ADAPTAID TEMP. PACING EXT. LEAD #366-02
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K801064 · Daig Corp. · May 1980