Cleared Traditional

K800379 - BIFOCAL 2 8200 SERIES (A,B C,D)

K800379 is an FDA 510(k) clearance for BIFOCAL 2 8200 SERIES (A, 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 217-day FDA review.

K800379 · American Pacemaker Corp. · Cardiovascular device
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Sep 1980
Decision
217d
Days
Class 3
Risk

K800379 is an FDA 510(k) clearance for the BIFOCAL 2 8200 SERIES (A,B C,D). 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 September 26, 1980 after a review of 217 days - an extended review 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 - K800379

510(k) Number K800379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1980
Decision Date September 26, 1980
Days to Decision 217 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K800379.
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · Cardiac Pacemakers, Inc. · Oct 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · Cardiac Pacemakers, Inc. · Oct 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · Bentley Laboratories, Inc. · Oct 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · Pacesetter Systems · Sep 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · Telectronics, Inc. · Sep 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · Telectronics, Inc. · Sep 1980