Cleared Traditional

K990510 - JMS APHERESIS NEEDLE

K990510 is an FDA 510(k) clearance for JMS APHERESIS NEEDLE, manufactured by Jms Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K990510 · Jms Co., Ltd. · Gastroenterology & Urology device
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Aug 1999
Decision
193d
Days
Class 2
Risk

K990510 is an FDA 510(k) clearance for the JMS APHERESIS NEEDLE. 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 August 30, 1999 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jms Co., Ltd. devices

FDA 510(k) Submission Details - K990510

510(k) Number K990510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date August 30, 1999
Days to Decision 193 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
62d slower than avg
Panel avg: 131d · This submission: 193d
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 K990510.
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118 · Bioteque Corp. · Dec 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · Diasol, Inc. · Oct 1999
JMS A. V. FISTULA NEEDLE SET
K990470 · Jms Co., Ltd. · Aug 1999
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623 · Nipro Medical Corp. · Aug 1999
JMS APHERESIS NEEDLE
K974902 · Jms Co., Ltd. · Mar 1998
JMS AV FISTULA NEEDLE
K970962 · Jms Co., Ltd. · Aug 1997