Cleared Traditional

K860789 - JMD AV FISTULA NEEDLE (MODIFICATION)

K860789 is the FDA 510(k) clearance for JMD AV FISTULA NEEDLE (MODIFICATION) by Jms Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FIE) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K860789 · Jms Co., Ltd. · Gastroenterology & Urology device
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Mar 1986
Decision
20d
Days
Class 2
Risk

K860789 is an FDA 510(k) clearance for the JMD AV FISTULA NEEDLE (MODIFICATION). 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 18, 1986 after a review of 20 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 Jms Co., Ltd. devices

Submission Details

510(k) Number K860789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1986
Decision Date March 18, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
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 K860789.
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
HOSPAL FISTULA NEEDLE
K851453 · Hospal Medical Corp. · Apr 1985
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983