Cleared Traditional

K821547 - PACEMAKER UNIPOLAR ADAPTER

K821547 is the FDA 510(k) clearance for PACEMAKER UNIPOLAR ADAPTER by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K821547 · Pacesetter Systems · Cardiovascular device
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Jun 1982
Decision
8d
Days
Class 2
Risk

K821547 is an FDA 510(k) clearance for the PACEMAKER UNIPOLAR ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 8 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 K821547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1982
Decision Date June 02, 1982
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 K821547.
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · Telectronics, Inc. · May 1984
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · Cardiac Pacemakers, Inc. · May 1983
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · Intermedics, Inc. · Nov 1982
PACEMAKER CONNECTOR PLUG
K821548 · Pacesetter Systems · Jun 1982
PACEMAKER 445 ADAPTER
K821549 · Pacesetter Systems · Jun 1982
MODEL 5866-26 LEAD ADAPTER KIT
K820935 · Medtronic Vascular · Apr 1982