Cleared Traditional

K921318 - ADAPTING SLEEVE KIT MODEL 4023

K921318 is an FDA 510(k) clearance for ADAPTING SLEEVE KIT MODEL 4023, manufactured by Siemens-Pacesetter, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K921318 · Siemens-Pacesetter, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
137d
Days
Class 2
Risk

K921318 is an FDA 510(k) clearance for the ADAPTING SLEEVE KIT MODEL 4023. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Siemens-Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 137 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 Siemens-Pacesetter, Inc. devices

FDA 510(k) Submission Details - K921318

510(k) Number K921318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date August 03, 1992
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 K921318.
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
UNIPOLAR UPSIZING ADAPTOR
K912773 · Telectronics Pacing Systems, Inc. · Oct 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · Biotronik, GmbH & Co. · Aug 1991