Cleared Traditional

K801640 - SORIN PULSE GENERATOR

K801640 is the FDA 510(k) clearance for SORIN PULSE GENERATOR by Bentley Laboratories, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K801640 · Bentley Laboratories, Inc. · Cardiovascular device
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Oct 1980
Decision
78d
Days
Class 3
Risk

K801640 is an FDA 510(k) clearance for the SORIN PULSE GENERATOR, MODEL #LIT-214. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 78 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K801640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1980
Decision Date October 03, 1980
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K801640.
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · Siemens Elema AB · Dec 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · Cardiac Pacemakers, Inc. · Oct 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · Cardiac Pacemakers, 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