Not Cleared Traditional

K971930 - BK-N SEALING CAP

K971930 is an FDA 510(k) submission for BK-N SEALING CAP, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K971930 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
79d
Days
Class 2
Risk

K971930 is an FDA 510(k) submission (not cleared) for the BK-N SEALING CAP. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on August 14, 1997 after a review of 79 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

FDA 510(k) Submission Details - K971930

510(k) Number K971930 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received May 27, 1997
Decision Date August 14, 1997
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 102
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K971930.
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular · Feb 2000
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · Medtronic Vascular · Oct 1998
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · Biotronik, Inc. · Aug 1997
BK-A
K970204 · Biotronik, Inc. · Apr 1997
IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
K950140 · Pacesetter, Inc. · Apr 1995
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · Telectronics Pacing Systems, Inc. · May 1994
K971930 · BK-N SEALING CAP
Download PDF Biotronik, Inc.