Cleared Traditional

K900605 - 3.2-5MM UNIPOLAR LEAD UPSIZING KIT

K900605 is the FDA 510(k) clearance for 3.2-5MM UNIPOLAR LEAD UPSIZING KIT by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K900605 · Possis Medical, Inc. · Cardiovascular device
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Mar 1990
Decision
26d
Days
Class 2
Risk

K900605 is an FDA 510(k) clearance for the 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 26 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 Possis Medical, Inc. devices

Submission Details

510(k) Number K900605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date March 06, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
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 74
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K900605.
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · Pacesetter Systems · Jun 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
IMPLANTABLE ADAPTOR 033-380
K890895 · Telectronics, Inc. · Mar 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
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986