Cleared Traditional

K801041 - 3M R.F. CURRENT SUPPRESSOR

K801041 is the FDA 510(k) clearance for 3M R.F. CURRENT SUPPRESSOR by 3M Company. It is a Class 2 Cardiovascular device (product code DSA) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801041 · 3M Company · Cardiovascular device
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May 1980
Decision
21d
Days
Class 2
Risk

K801041 is an FDA 510(k) clearance for the 3M R.F. CURRENT SUPPRESSOR. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 21 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 3M Company devices

Submission Details

510(k) Number K801041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1980
Decision Date May 23, 1980
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 47
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K801041.
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · Medtronic Vascular · Jan 1989
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · Medtronic Vascular · Mar 1988
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · Intermedics, Inc. · Mar 1982
DISPOSABLE PATIENT CABLE MODEL 5807
K801064 · Daig Corp. · May 1980
RF CHOKE CABLE
K771750 · C.R. Bard, Inc. · Sep 1977