Cleared Traditional

K885101 - MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR

K885101 is an FDA 510(k) clearance for MEDTRONIC MODEL 5411B SURGICAL CABLE AD..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K885101 · Medtronic Vascular · Cardiovascular device
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Jan 1989
Decision
31d
Days
Class 2
Risk

K885101 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 12, 1989 after a review of 31 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.

FDA 510(k) Submission Details - K885101

510(k) Number K885101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date January 12, 1989
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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 105
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K885101.
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
K894981 · Medtronic Vascular · Sep 1989
ASTRO TRACE (MODEL AT-02)
K885137 · The LE Blanc Corp. · Mar 1989
ASTRO TRACE (MODEL AT-01)
K884592 · The LE Blanc Corp. · Mar 1989
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
K882174 · Medtronic Andover Medical, Inc. · Jul 1988
ELECTRODE CABLE
K880320 · Vital Connections, Inc. · Mar 1988
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · Medtronic Vascular · Mar 1988
K885101 · MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
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