Cleared Traditional

K221020 - Accuryn Monitoring System

K221020 is an FDA 510(k) clearance for Accuryn Monitoring System, manufactured by Potrero Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 282-day FDA review.

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

FDA 510(k) Submission Details - K221020

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.

EZL Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K221020.
2-Way 100% Silicone Cleartract Catheter
K233013 · Silq Technologies Corporation · Jan 2024
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · Teleflexmedical, Inc. · Jul 2023
Flume Catheter
K231101 · Flume Catheter Company, Ltd. · Jun 2023
2-Way 100% Silicone Cleartract Catheter
K222118 · Silq Technologies, Corp. · Dec 2022
2-Way 100% Silicone ClearTract Catheter
K221625 · Silq Technologies Corporation · Jul 2022
FLUME catheter
K212151 · The Flume Catheter Company, Ltd. · Nov 2021