Cleared Traditional

K251877 - JMS CAVEO A.V. Fistula Needle Set (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K251877 · JMS North America Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
58d
Days
Class 2
Risk

K251877 is an FDA 510(k) clearance for the JMS CAVEO A.V. Fistula Needle Set. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on August 15, 2025 after a review of 58 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 Corporation devices

Submission Details

510(k) Number K251877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2025
Decision Date August 15, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05493423 Completed Interventional Industry-sponsored

Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis

Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis: Clinic-SAVER

15
Patients (actual)
1
Site
Prevention
Purpose
Open label
Masking
Condition studied End Stage Renal Disease
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Wesley Calhoun, MD
Sponsor Hemotek Medical Inc (industry)
Started 2022-11-07 → Primary completion 2023-07-10 → Completed 2023-07-17
Primary outcome
Percentage of Successful Hemodialysis Sessions
View full study on ClinicalTrials.gov