Cleared Traditional

K914109 - PIKOS 01 & PIKOS E 01

K914109 is an FDA 510(k) clearance for PIKOS 01 & PIKOS E 01, 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 166-day FDA review.

K914109 · Biotronik, GmbH & Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
166d
Days
Class 3
Risk

K914109 is an FDA 510(k) clearance for the PIKOS 01 & PIKOS E 01. 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 February 26, 1992 after a review of 166 days - an extended review 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, GmbH & Co. devices

FDA 510(k) Submission Details - K914109

510(k) Number K914109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date February 26, 1992
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
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 K914109.
ASTRA T2, ASTRA T4, ASTRA T6
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K905403 · Cook Pacemaker Corp. · Oct 1991
MODEL 4220
K913134 · Pace Medical · Aug 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · Pace Medical · Jul 1991