Cleared Special

K993434 - PIKOS 01

K993434 is the FDA 510(k) clearance for PIKOS 01 by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K993434 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
29d
Days
Class 3
Risk

K993434 is an FDA 510(k) clearance for the PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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, Inc. devices

Submission Details

510(k) Number K993434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date November 10, 1999
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 314
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K993434.
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · Ela Medical, Inc. · Aug 1997
PIKOS LP 01, PIKOS LP E01
K945627 · Biotronik, Inc. · Mar 1996
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · Medtronic Vascular · Dec 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · Medtronic Vascular · Dec 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · Biotronik, Inc. · Sep 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · Ela Medical, Inc. · Sep 1995