Cleared Traditional

K920634 - SPLITTABLE SHEATH INTRODUCER SET

K920634 is the FDA 510(k) clearance for SPLITTABLE SHEATH INTRODUCER SET by Akcess Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LFJ) cleared through the Traditional 510(k) pathway after a 702-day FDA review.

K920634 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
702d
Days
Class 2
Risk

K920634 is an FDA 510(k) clearance for the SPLITTABLE SHEATH INTRODUCER SET. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 702 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K920634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date January 14, 1994
Days to Decision 702 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
572d slower than avg
Panel avg: 130d · This submission: 702d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LFJ Catheter, Subclavian

All 47
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K920634.
AKCESS0CATH KIT
K925819 · Akcess Medical Products, Inc. · Aug 1994
AKCESS-CATH
K925818 · Akcess Medical Products, Inc. · Apr 1994
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
K913468 · Cook, Inc. · Mar 1994
COAXIAL ACUTE CATHETER
K931120 · Akcess Medical Products, Inc. · Jan 1994
HEMO-CATH SILICONE ACCESS CATHETER
K915423 · Medical Components, Inc. · Feb 1993
AKCESS-CATH KIT
K914826 · Akcess Medical Products, Inc. · Apr 1992