Cleared Traditional

K253469 - Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)

Also marketed or referenced as:
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM) Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM) Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM) Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM) Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)

K253469 is an FDA 510(k) clearance for Ritus Safety Fistula Cannula with Anti-..., manufactured by Mozarc Medical Us, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K253469 · Mozarc Medical Us, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
300d
Days
Class 2
Risk

K253469 is an FDA 510(k) clearance for the Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM). Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Mozarc Medical Us, LLC (Mansfield, US). The FDA issued a Cleared decision on August 6, 2026 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Mozarc Medical Us, LLC devices

FDA 510(k) Submission Details - K253469

510(k) Number K253469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2025
Decision Date August 06, 2026
Days to Decision 300 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
169d slower than avg
Panel avg: 131d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

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

Regulatory Consultant

Mozarc Medical
Carol Ming

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05927532 Completed Interventional Industry-sponsored

Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study

Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study

40
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Failure on Dialysis
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Mozarc Medical US LLC (industry)
Started 2024-03-10 → Primary completion 2024-12-15
Primary outcome
Successful Hemodialysis Sessions
Secondary outcome
Successful Cannulations
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - FIE Needle, Fistula

All 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K253469.
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
DORA Disposable A.V. Fistula Needle Sets
K163025 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jul 2017
JMS Harmony A.V. Fistula Needle Set
K151017 · JMS North America Corporation · May 2015
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950 · Summit International Medical Technologies, Inc. · Jan 2015