Cleared Traditional

K915174 - JMS APHERESIS NEEDLE

K915174 is the FDA 510(k) clearance for JMS APHERESIS NEEDLE by Jms Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FIE) cleared through the Traditional 510(k) pathway after a 473-day FDA review.

K915174 · Jms Co., Ltd. · Gastroenterology & Urology device
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Mar 1993
Decision
473d
Days
Class 2
Risk

K915174 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 March 2, 1993 after a review of 473 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Jms Co., Ltd. devices

Submission Details

510(k) Number K915174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date March 02, 1993
Days to Decision 473 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 130d · This submission: 473d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K915174.
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