Cleared Traditional

K911827 - MODEL 5866-9M & MODEL 6981M

K911827 is the FDA 510(k) clearance for MODEL 5866-9M & MODEL 6981M by Metronic, Inc.. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911827 · Metronic, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1991
Decision
90d
Days
Class 2
Risk

K911827 is an FDA 510(k) clearance for the MODEL 5866-9M & MODEL 6981M. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 23, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Metronic, Inc. devices

Submission Details

510(k) Number K911827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1991
Decision Date July 23, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 85
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K911827.
BK-A
K970204 · Biotronik, Inc. · Apr 1997
MODEL 6984M LEAD EXTENDER KIT
K915724 · Medtronic Vascular · Feb 1992
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · Medtronic Vascular · Jul 1991
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