Cleared Traditional

K983707 - JMS DIALYZER PRIMING SET

K983707 is the FDA 510(k) clearance for JMS DIALYZER PRIMING SET by Jms Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K983707 · Jms Co., Ltd. · Gastroenterology & Urology device
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Jan 1999
Decision
79d
Days
Class 2
Risk

K983707 is an FDA 510(k) clearance for the JMS DIALYZER PRIMING SET. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on January 8, 1999 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 K983707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date January 08, 1999
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 116
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K983707.
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K955277 · Baxter Healthcare Corp · Feb 1996
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