Cleared Traditional

K791955 - UNIFOCAL 1 UNIPOLAR DEMAND R WAVE

K791955 is an FDA 510(k) clearance for UNIFOCAL 1 UNIPOLAR DEMAND R WAVE, manufactured by American Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K791955 · American Pacemaker Corp. · Cardiovascular device
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Nov 1979
Decision
57d
Days
Class 3
Risk

K791955 is an FDA 510(k) clearance for the UNIFOCAL 1 UNIPOLAR DEMAND R WAVE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by American Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 57 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 American Pacemaker Corp. devices

FDA 510(k) Submission Details - K791955

510(k) Number K791955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1979
Decision Date November 27, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791955.
CARDIAC PACEMAKER P4000 SER. & P1000
K791920 · Vitatron Medical BV · Nov 1979
ARCOLITH 2100-CARDIAC PULSE GENERATOR
K792216 · Arco Medical Products Co. · Nov 1979
ARCOLITH 3020-CARDIAC PULSE GENERATOR
K792299 · Arco Medical Products Co. · Nov 1979
MEDTRONIC MODELS 5984/5985
K791316 · Medtronic Vascular · Nov 1979
CARDIAC PACEMAKER C4000, C1000 SER.
K791921 · Vitatron Medical BV · Oct 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · Cordis Corp. · Oct 1979