Cleared Traditional

K854405 - PACESETTER SYSTEMS ENDOCARDIAL SMALL FI...

K854405 is the FDA 510(k) clearance for PACESETTER SYSTEMS ENDOCARDIAL SMALL FI... by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K854405 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
33d
Days
Class 3
Risk

K854405 is an FDA 510(k) clearance for the PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN 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 33 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 K854405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1985
Decision Date December 04, 1985
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 K854405.
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · Intermedics, Inc. · Dec 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · Intermedics, Inc. · Dec 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · 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
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519 · Intermedics, Inc. · Oct 1985