Cleared Traditional

K810551 - PACEMAKER LEAD ADAPTER

K810551 is the FDA 510(k) clearance for PACEMAKER LEAD ADAPTER by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K810551 · Pacesetter Systems · Cardiovascular device
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Apr 1981
Decision
52d
Days
Class 2
Risk

K810551 is an FDA 510(k) clearance for the PACEMAKER LEAD ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Walker, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 52 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 K810551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1981
Decision Date April 23, 1981
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K810551.
ADAPTAID LEAD ADAPTER, #365-17
K811920 · Intermedics, Inc. · Aug 1981
ADAPTAID LEAD ADAPTER #365-25
K811938 · Intermedics, Inc. · Aug 1981
MODEL 5866-24 LEAD ADAPTOR KIT
K811349 · Medtronic Vascular · Jun 1981
IMPLANTABLE PACEMAKER LEAD ADAPTER
K810245 · Intermedics, Inc. · Mar 1981
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · Pacesetter Systems · Oct 1980
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER
K802077 · Cardiac Pacemakers, Inc. · Oct 1980