Cleared Traditional

K911827 - MODEL 5866-9M & MODEL 6981M

K911827 is an FDA 510(k) clearance for MODEL 5866-9M & MODEL 6981M, manufactured by Metronic, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K911827

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.

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 97
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K911827.
UNIPOLAR UPSIZING ADAPTOR
K912773 · Telectronics Pacing Systems, Inc. · Oct 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · Biotronik, GmbH & Co. · Aug 1991
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
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · Telectronics Pacing Systems, Inc. · Feb 1991