Cleared Traditional

K894494 - LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

K894494 is an FDA 510(k) clearance for LABELING CHANGES TO PULSE GENE. & PULSE..., manufactured by Biotronik, GmbH & Co.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K894494 · Biotronik, GmbH & Co. · Cardiovascular device
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Oct 1989
Decision
90d
Days
Class 3
Risk

K894494 is an FDA 510(k) clearance for the LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik, GmbH & Co. (Lake Oswego, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 90 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, GmbH & Co. devices

FDA 510(k) Submission Details - K894494

510(k) Number K894494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date October 17, 1989
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K894494.
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
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · Medtronic Vascular · Sep 1989
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, Inc. · Sep 1989