Cleared Traditional

K902889 - A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.

K902889 is an FDA 510(k) clearance for A1-A, manufactured by Biotronik, GmbH & Co.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K902889 · Biotronik, GmbH & Co. · Cardiovascular device
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Aug 1990
Decision
52d
Days
Class 2
Risk

K902889 is an FDA 510(k) clearance for the A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik, GmbH & Co. (Lake Oswego, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biotronik, GmbH & Co. devices

FDA 510(k) Submission Details - K902889

510(k) Number K902889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date August 23, 1990
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 95
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K902889.
MODEL 5857-3M LEAD END CAP KIT
K911048 · Medtronic Vascular · Apr 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · Telectronics Pacing Systems, Inc. · Feb 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · Medtronic Vascular · Feb 1991
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · Pacesetter Systems · Jun 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K896438 · Telectronics Pacing Systems, Inc. · Apr 1990