Cleared Traditional

K896184 - KALOS 05 PULSE GENERATOR

K896184 is an FDA 510(k) clearance for KALOS 05 PULSE GENERATOR, manufactured by Biotronik Cardiac Pacemakers. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K896184 · Biotronik Cardiac Pacemakers · Cardiovascular device
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Jan 1990
Decision
85d
Days
Class 3
Risk

K896184 is an FDA 510(k) clearance for the KALOS 05 PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Cardiac Pacemakers (Lake Oswego, US). The FDA issued a Cleared decision on January 18, 1990 after a review of 85 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 Cardiac Pacemakers devices

FDA 510(k) Submission Details - K896184

510(k) Number K896184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date January 18, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K896184.
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116 · Telectronics Pacing Systems, Inc. · Mar 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · Ela Medical, Inc. · Mar 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · Medtronic Vascular · Jan 1990
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494 · Biotronik, GmbH & Co. · Oct 1989
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · Medtronic Vascular · Sep 1989