Cleared Traditional

K770197 - UNIPOLAR

K770197 is the FDA 510(k) clearance for UNIPOLAR by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770197 · Cardiac Pacemakers, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1977
Decision
7d
Days
Class 3
Risk

K770197 is an FDA 510(k) clearance for the UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1977 after a review of 7 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K770197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1977
Decision Date February 07, 1977
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 279
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K770197.
GENERATOR, PULSE, UNIPOLAR, MODEL #504
K770716 · Cardiac Pacemakers, Inc. · Apr 1977
GENERATOR, PULSE, BIPOLAR, MODEL #604
K770715 · Cardiac Pacemakers, Inc. · Apr 1977
CENTURION
K770419 · Johnson & Johnson Professionals, Inc. · Apr 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198 · Cardiac Pacemakers, Inc. · Feb 1977
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143 · Pacesetter Systems · Dec 1976
MODEL 100 CARDIAC PACEMAKER
K760757 · Pacesetter Systems · Nov 1976