Cleared Traditional

K904255 - FOCUS T41,T41F,T43, T43F,T44F

K904255 is an FDA 510(k) clearance for FOCUS T41, manufactured by Elamedical. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K904255 · Elamedical · Cardiovascular device
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Jan 1991
Decision
123d
Days
Class 3
Risk

K904255 is an FDA 510(k) clearance for the FOCUS T41,T41F,T43, T43F,T44F. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Elamedical (Minnetonka, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Elamedical devices

FDA 510(k) Submission Details - K904255

510(k) Number K904255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date January 18, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K904255.
PERMANENT PACING LEAD
K905300 · Oscor Medical Corp. · May 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · Intermedics, Inc. · Apr 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · Intermedics, Inc. · Mar 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · Telectronics Pacing Systems, Inc. · Jan 1991
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221 · Telectronics Pacing Systems, Inc. · Nov 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927 · Biotronik, GmbH & Co. · Oct 1990