Cleared Traditional

K911199 - JMS AV FISTULA NEEDLES

K911199 is an FDA 510(k) clearance for JMS AV FISTULA NEEDLES, 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 175-day FDA review.

K911199 · Jms Co., Ltd. · Gastroenterology & Urology device
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Aug 1991
Decision
175d
Days
Class 2
Risk

K911199 is an FDA 510(k) clearance for the JMS AV FISTULA NEEDLES. 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 28, 1991 after a review of 175 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 - K911199

510(k) Number K911199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date August 28, 1991
Days to Decision 175 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
44d slower than avg
Panel avg: 131d · This submission: 175d
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 K911199.
BRAUN DIACAN(R) FISTULA NEEDLES
K945850 · B. Braun of America, Inc. · Oct 1995
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K932074 · Medisystems Corp. · Feb 1994
JMS APHERESIS NEEDLE
K915174 · Jms Co., Ltd. · Mar 1993
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · Medisystems Corp. · Jun 1991
EXEL A-V FISTULA SET
K903945 · Exel Intl. · Nov 1990
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990