Cleared Traditional

K950140 - IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069

K950140 is an FDA 510(k) clearance for IS-1/QUADRIPOLAR TERMINAL CAP, manufactured by Pacesetter, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K950140 · Pacesetter, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
83d
Days
Class 2
Risk

K950140 is an FDA 510(k) clearance for the IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 83 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 Pacesetter, Inc. devices

FDA 510(k) Submission Details - K950140

510(k) Number K950140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1995
Decision Date April 06, 1995
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K950140.
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · Biotronik, Inc. · Aug 1997
BK-N SEALING CAP
K971930 · Biotronik, Inc. · Aug 1997
BK-A
K970204 · Biotronik, Inc. · Apr 1997
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · Telectronics Pacing Systems, Inc. · May 1994
MISCELLANEOUS PACING LEAD
K925168 · Oscor Medical Corp. · May 1994
MODEL 6984M LEAD EXTENDER KIT
K915724 · Medtronic Vascular · Feb 1992