Cleared Traditional

K844812 - NEOS - PULSE GENERATOR

K844812 is an FDA 510(k) clearance for NEOS - 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 128-day FDA review.

K844812 · Biotronik Sales, Inc. · Cardiovascular device
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Apr 1985
Decision
128d
Days
Class 3
Risk

K844812 is an FDA 510(k) clearance for the NEOS - 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 April 18, 1985 after a review of 128 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.

View all Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K844812

510(k) Number K844812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date April 18, 1985
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K844812.
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · Pacesetter Systems · May 1985
LEPTOS PULSE GENERATOR
K844794 · Biotronik Sales, Inc. · Apr 1985
NEOS-M PULSE GENERATOR
K844795 · Biotronik Sales, Inc. · Apr 1985
KALOS-04 PULSE GENERATOR
K844841 · Biotronik Sales, Inc. · Apr 1985
NEOS-LP PULSE GENERATOR
K844842 · Biotronik Sales, Inc. · Apr 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252 · Telectronics, Inc. · Apr 1985