Cleared Traditional

K896742 - FOCUS J81F

K896742 is the FDA 510(k) clearance for FOCUS J81F by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K896742 · Ela Medical, Inc. · Cardiovascular device
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Jul 1990
Decision
229d
Days
Class 3
Risk

K896742 is an FDA 510(k) clearance for the FOCUS J81F, J83F, J41F, J43F PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 229 days - an extended review cycle.

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 Ela Medical, Inc. devices

Submission Details

510(k) Number K896742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1989
Decision Date July 17, 1990
Days to Decision 229 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 slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K896742.
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
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · Medtronic Vascular · Sep 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · Pacesetter Systems · Jul 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · Pacesetter Systems · Apr 1990