Cleared Traditional

K854220 - PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD

K854220 is the FDA 510(k) clearance for PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K854220 · Pacesetter Systems · Cardiovascular device
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Dec 1985
Decision
47d
Days
Class 3
Risk

K854220 is an FDA 510(k) clearance for the PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 47 days - a notably fast clearance 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 Pacesetter Systems devices

Submission Details

510(k) Number K854220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1985
Decision Date December 04, 1985
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K854220.
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517 · Intermedics, Inc. · Dec 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · Intermedics, Inc. · Dec 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · Intermedics, Inc. · Dec 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · Pacesetter Systems · Dec 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · Pacesetter Systems · Dec 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518 · Intermedics, Inc. · Nov 1985