Cleared Traditional

K761143 - LITHIUM IODIDE BATTERY PACEMAKER (#201)

K761143 is the FDA 510(k) clearance for LITHIUM IODIDE BATTERY PACEMAKER (#201) by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K761143 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
27d
Days
Class 3
Risk

K761143 is an FDA 510(k) clearance for the LITHIUM IODIDE BATTERY PACEMAKER (#201). Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on December 23, 1976 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 K761143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date December 23, 1976
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K761143.
CENTURION
K770419 · Johnson & Johnson Professionals, Inc. · Apr 1977
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197 · Cardiac Pacemakers, Inc. · Feb 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198 · Cardiac Pacemakers, Inc. · Feb 1977
MODEL 100 CARDIAC PACEMAKER
K760757 · Pacesetter Systems · Nov 1976