Cleared Traditional

K212868 - JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (FDA 510(k) Clearance)

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

K212868 · Rocamed Sam · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
139d
Days
Class 2
Risk

K212868 is an FDA 510(k) clearance for the JFil Ureteral Stents, JFil Ureteral Stents ECO KIT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Rocamed Sam (Monaco, MC). The FDA issued a Cleared decision on January 26, 2022 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 Rocamed Sam devices

Submission Details

510(k) Number K212868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2021
Decision Date January 26, 2022
Days to Decision 139 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
9d slower than avg
Panel avg: 130d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K212868.
Disposable Ureteral Stents
K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2026
Endura™ Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Disposable ureteral stent
K243830 · Shenzhen Trious Medical Technology Co., Ltd. · May 2025
Percuflex Ureteral Stent
K250824 · Boston Scientific Corporation · Apr 2025
RELIEF™ Ureteral Stent Kit
K232920 · Ureteral Stent Company · Mar 2024