Cleared Traditional

K905087 - TRIOS 02

K905087 is an FDA 510(k) clearance for TRIOS 02, 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 175-day FDA review.

K905087 · Biotronik, GmbH & Co. · Cardiovascular device
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May 1991
Decision
175d
Days
Class 3
Risk

K905087 is an FDA 510(k) clearance for the TRIOS 02. 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 May 7, 1991 after a review of 175 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 - K905087

510(k) Number K905087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date May 07, 1991
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 K905087.
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · Pace Medical · Jul 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · Cardiac Control Systems, Inc. · May 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
K903186 · Telectronics Pacing Systems, Inc. · Jan 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · Medtronic Vascular · Jan 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941 · Cardiac Control Systems, Inc. · Jan 1991