Cleared Traditional

K792565 - SORIN PULSE GENERATOR MODEL # LIT 214 H

K792565 is the FDA 510(k) clearance for SORIN PULSE GENERATOR MODEL # LIT 214 H by Bentley Laboratories, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K792565 · Bentley Laboratories, Inc. · Cardiovascular device
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Feb 1980
Decision
60d
Days
Class 3
Risk

K792565 is an FDA 510(k) clearance for the SORIN PULSE GENERATOR MODEL # LIT 214 H. 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 February 5, 1980 after a review of 60 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 K792565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1979
Decision Date February 05, 1980
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 K792565.
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · Intermedics, Inc. · Apr 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573 · Telectronics, Inc. · Mar 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526 · Bentley Laboratories, Inc. · Feb 1980
MICROTHIN-DI
K800026 · Cardiac Pacemakers, Inc. · Jan 1980
MICROTHIN-PI
K800027 · Cardiac Pacemakers, Inc. · Jan 1980
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
K800030 · Telectronics, Inc. · Jan 1980