Cleared Traditional

K812325 - INTK-08 8 FRENCH INTRODUCER KIT W/SIDE

K812325 is the FDA 510(k) clearance for INTK-08 8 FRENCH INTRODUCER KIT W/SIDE by Sorensen Research. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K812325 · Sorensen Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
35d
Days
Class 2
Risk

K812325 is an FDA 510(k) clearance for the INTK-08 8 FRENCH INTRODUCER KIT W/SIDE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Sorensen Research devices

Submission Details

510(k) Number K812325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date September 21, 1981
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 324
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K812325.
INTRODUCER SET
K821188 · Advanced Cardiovascular Systems, Inc. · Jul 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
CATHETER INTRODUCERS, ARTERISE
K781954 · C.R. Bard, Inc. · Nov 1978
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · Arrow Intl., Inc. · Apr 1978