Cleared Traditional

K863879 - NEOS-M VS-1 PULSE GENERATOR

K863879 is an FDA 510(k) clearance for NEOS-M VS-1 PULSE GENERATOR, 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 65-day FDA review.

K863879 · Biotronik Sales, Inc. · Cardiovascular device
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Dec 1986
Decision
65d
Days
Class 3
Risk

K863879 is an FDA 510(k) clearance for the NEOS-M VS-1 PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 65 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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K863879

510(k) Number K863879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1986
Decision Date December 10, 1986
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 K863879.
EDP-20 PACEMAKER
K860036 · Biotronik Sales, Inc. · Jan 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · Medtronic Vascular · Jan 1987
TRIOS-M VS-1 PULSE GENERATOR
K863878 · Biotronik Sales, Inc. · Dec 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
K863582 · Cook Pacemaker Corp. · Oct 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · Intermedics, Inc. · Sep 1986