Cleared Traditional

K841635 - LEPTOS

K841635 is an FDA 510(k) clearance for LEPTOS, manufactured by Biotronik Sales, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K841635 · Biotronik Sales, Inc. · Cardiovascular device
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Aug 1984
Decision
106d
Days
Class 3
Risk

K841635 is an FDA 510(k) clearance for the LEPTOS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 106 days - within the typical 510(k) review window.

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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FDA 510(k) Submission Details - K841635

510(k) Number K841635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1984
Decision Date August 03, 1984
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
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 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K841635.
MEDTRONIC 5984-5984LP-5985
K843837 · Medtronic Vascular · Oct 1984
MEDTRONIC 8437/8438
K843089 · Medtronic Vascular · Aug 1984
NEOS LP
K841633 · Biotronik Sales, Inc. · Aug 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · Cook Pacemaker Corp. · Jul 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983 · Cook Pacemaker Corp. · Jul 1984
PULSE GENERATOR 678L
K841233 · Siemens Elema AB · Jul 1984