Cleared Traditional

A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. (K902889) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 37
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K902889.
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · Medtronic Vascular · Apr 1991
MODEL 5857-3M LEAD END CAP KIT
K911048 · Medtronic Vascular · Apr 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · Medtronic Vascular · Feb 1991
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · Medtronic Vascular · Oct 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · Intermedics, Inc. · Sep 1989