Cleared Traditional

Accuryn Monitoring System (K153655) - FDA 510(k) Clearance

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

K153655 · Potrero Medical, Inc. · Gastroenterology & Urology device
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Apr 2016
Decision
116d
Days
Class 2
Risk

K153655 is an FDA 510(k) clearance for the Accuryn Monitoring System. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Potrero Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 15, 2016 after a review of 116 days - within the typical 510(k) review window.

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 K153655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 21, 2015
Decision Date April 15, 2016
Days to Decision 116 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 130d · This submission: 116d
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 43
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K153655.
Silicone Foley Catheter for single use
K172807 · Changzhou Rongxin Medicine Minimal Invasion Technology · Jun 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · Poiesis Medical, LLC · Mar 2018
Kohli Urinary Drainage Catheter
K172422 · Nellie Medical, LLC · Feb 2018
Bard LubriGuard Foley Catheter
K150699 · C.R. Bard, Inc. · Jul 2015
Medline Silicone Foley Catheter
K142635 · Medline Industries, Inc. · Jan 2015
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc. · Dec 2007