Cleared Traditional

K903945 - EXEL A-V FISTULA SET

K903945 is an FDA 510(k) clearance for EXEL A-V FISTULA SET, manufactured by Exel Intl.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K903945 · Exel Intl. · Gastroenterology & Urology device
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Nov 1990
Decision
85d
Days
Class 2
Risk

K903945 is an FDA 510(k) clearance for the EXEL A-V FISTULA SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Exel Intl. (Culver City, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 85 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 Exel Intl. devices

FDA 510(k) Submission Details - K903945

510(k) Number K903945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1990
Decision Date November 20, 1990
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
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 - FIE Needle, Fistula

All 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K903945.
JMS APHERESIS NEEDLE
K915174 · Jms Co., Ltd. · Mar 1993
JMS AV FISTULA NEEDLES
K911199 · Jms Co., Ltd. · Aug 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · Medisystems Corp. · Jun 1991
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
JMS APHERESIS NEEDLE
K880726 · Jms Co., Ltd. · Mar 1988