Cleared Traditional

K923026 - PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER

K923026 is an FDA 510(k) clearance for PIKOS 01-A AND PIKOS E01-A IMPLANTABLE ..., 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 422-day FDA review.

K923026 · Biotronik, GmbH & Co. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1993
Decision
422d
Days
Class 3
Risk

K923026 is an FDA 510(k) clearance for the PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER. 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 August 19, 1993 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Biotronik, GmbH & Co. devices

FDA 510(k) Submission Details - K923026

510(k) Number K923026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date August 19, 1993
Days to Decision 422 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 125d · This submission: 422d
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 K923026.
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
K950210 · Cardiac Control Systems, Inc. · May 1995
PIKOS E 01-B
K941937 · Biotronik, Inc. · Aug 1994
MINIX/MINIX ST PULSE GENERATORS
K932884 · Medtronic Vascular · May 1994
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868 · Cardiac Control Systems, Inc. · May 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · Medtronic Vascular · May 1993
ASTRA T2, ASTRA T4, ASTRA T6
K920601 · Cardiac Pacemakers, Inc. · Oct 1992