Cleared Traditional

K891755 - DUAL LUMEN SUB-CLAVIAN CATH KIT

K891755 is the FDA 510(k) clearance for DUAL LUMEN SUB-CLAVIAN CATH KIT 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 77-day FDA review.

K891755 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Jun 1989
Decision
77d
Days
Class 2
Risk

K891755 is an FDA 510(k) clearance for the DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K. 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 June 8, 1989 after a review of 77 days - a notably fast clearance cycle.

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: 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 Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K891755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1989
Decision Date June 08, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
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 K891755.
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
K895417 · Arrow Intl., Inc. · Jan 1990
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · Medical Components, Inc. · Jun 1989
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · Akcess Medical Products, Inc. · Jun 1989
SUBCLAVIAN HEMODIALYSIS CATHETER
K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
K890029 · Medical Components, Inc. · Apr 1989
MEDSURG ACUTE DIALYSIS TRAY
K880778 · Medsurg Industries, Inc. · Jul 1988