Cleared Traditional

K854918 - MODEL 431-01 BIOPORE IMPLANTABLE PACING...

K854918 is an FDA 510(k) clearance for MODEL 431-01 BIOPORE IMPLANTABLE PACING..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854918 · Intermedics, Inc. · Cardiovascular device
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Mar 1986
Decision
92d
Days
Class 3
Risk

K854918 is an FDA 510(k) clearance for the MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 92 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K854918

510(k) Number K854918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date March 11, 1986
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K854918.
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985 · Intermedics, Inc. · Mar 1986
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986 · Intermedics, Inc. · Mar 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · Intermedics, Inc. · Mar 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128 · Oscor Medical Corp. · Feb 1986
DNR UNIPOLAR
K853568 · Biotronik Sales, Inc. · Jan 1986
STYLET INTRODUCER FUNNEL
K854142 · Telectronics, Inc. · Jan 1986