Cleared Traditional

PATIENT CABLE (K932704) - FDA 510(k) Clearance

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

K932704 · Sentry Medical Products, Inc. · Cardiovascular device
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Dec 1993
Decision
207d
Days
Class 2
Risk

K932704 is an FDA 510(k) clearance for the PATIENT CABLE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentry Medical Products, Inc. devices

Submission Details

510(k) Number K932704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date December 27, 1993
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K932704.
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
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RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
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MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
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