Cleared Traditional

K851665 - PACESETTER SYSTEMS

K851665 is the FDA 510(k) clearance for PACESETTER SYSTEMS by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K851665 · Pacesetter Systems · Cardiovascular device
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May 1985
Decision
29d
Days
Class 2
Risk

K851665 is an FDA 510(k) clearance for the PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pacesetter Systems devices

Submission Details

510(k) Number K851665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date May 21, 1985
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 84
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K851665.
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · Intermedics, Inc. · Jul 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · Intermedics, Inc. · Jul 1985
MEDTRONIC 5064
K851890 · Medtronic Vascular · Jun 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · Pacesetter Systems · Apr 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · Pacesetter Systems · Apr 1985
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
K844974 · Medtronic Vascular · Mar 1985