Cleared Traditional

K221020 - Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (FDA 510(k) Clearance)

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

K221020 · Potrero Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2023
Decision
282d
Days
Class 2
Risk

K221020 is an FDA 510(k) clearance for the Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, A.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Potrero Medical, Inc. (Hayward, US). The FDA issued a Cleared decision on January 13, 2023 after a review of 282 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Potrero Medical, Inc. devices

Submission Details

510(k) Number K221020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 06, 2022
Decision Date January 13, 2023
Days to Decision 282 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
152d slower than avg
Panel avg: 130d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZL Catheter, Retention Type, Balloon

All 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K221020.
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K252537 · Teleflex Medical Sdn. Bhd. · Jan 2026
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · Guangdong Ecan Medical Co., Ltd. · Jun 2025
InnoCare Specialty Foley Catheter
K241424 · Innocare Urologics, LLC · Sep 2024
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024
Folysil Silicone Catheter
K233411 · Coloplast Corp. · Apr 2024