Cleared Traditional

K901133 - DURACATH

K901133 is an FDA 510(k) clearance for DURACATH, manufactured by Impra, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K901133 · Impra, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
88d
Days
Class 2
Risk

K901133 is an FDA 510(k) clearance for the DURACATH. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 88 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 Impra, Inc. devices

FDA 510(k) Submission Details - K901133

510(k) Number K901133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date June 08, 1990
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K901133.
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
K905080 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1991
SINGLE LUMEN CATHETER KITS
K904139 · Akcess Medical Products, Inc. · Dec 1990
SINGLE LUMEN CATHETERS, MODIFICATION
K904140 · Akcess Medical Products, Inc. · Nov 1990
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
K901061 · Akcess Medical Products, Inc. · May 1990
DUALYSE-CATH - CODES #1132.212, 1132.112
K896568 · Vygon Corp. · May 1990
MODIFIED PERM-CATH
K900835 · Quinton, Inc. · May 1990