Cleared Traditional

JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 (K093637) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093637 · Jms North America Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
77d
Days
Class 2
Risk

K093637 is an FDA 510(k) clearance for the JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300,.... Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Jms North America Corp. (Crofton, US). The FDA issued a Cleared decision on February 9, 2010 after a review of 77 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 North America Corp. devices

Submission Details

510(k) Number K093637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2009
Decision Date February 09, 2010
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
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 78
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K093637.
JMS CAVEO A.V. Fistula Needle Set
K251877 · JMS North America Corporation · Aug 2025
DORA Disposable A.V. Fistula Needle Sets
K213015 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Apr 2022
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990