Cleared Special

K000845 - MODIFICATION TO JMS A.V. FISTULA NEEDLE...

K000845 is the FDA 510(k) clearance for MODIFICATION TO JMS A.V. FISTULA NEEDLE... by Jms Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FIE) cleared through the Special 510(k) pathway after a 26-day FDA review.

K000845 · Jms Co., Ltd. · Gastroenterology & Urology device
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Apr 2000
Decision
26d
Days
Class 2
Risk

K000845 is an FDA 510(k) clearance for the MODIFICATION TO JMS A.V. FISTULA NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on April 10, 2000 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jms Co., Ltd. devices

Submission Details

510(k) Number K000845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date April 10, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 22
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K000845.
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K134019 · Nxstage Medical, Inc. · Sep 2014
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · Nipro Medical Corporation · Mar 2010
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986