Cleared Traditional

K760757 - MODEL 100 CARDIAC PACEMAKER

K760757 is the FDA 510(k) clearance for MODEL 100 CARDIAC PACEMAKER by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K760757 · Pacesetter Systems · Cardiovascular device
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Nov 1976
Decision
41d
Days
Class 3
Risk

K760757 is an FDA 510(k) clearance for the MODEL 100 CARDIAC PACEMAKER. 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 November 11, 1976 after a review of 41 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.

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Submission Details

510(k) Number K760757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1976
Decision Date November 11, 1976
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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.