Cleared Traditional

K182635 - Signal Catheter

K182635 is the FDA 510(k) clearance for Signal Catheter by Safe Medical Design. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K182635 · Safe Medical Design · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
108d
Days
Class 2
Risk

K182635 is an FDA 510(k) clearance for the Signal Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Safe Medical Design (San Francisco, US). The FDA issued a Cleared decision on January 10, 2019 after a review of 108 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 Safe Medical Design devices

Submission Details

510(k) Number K182635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date January 10, 2019
Days to Decision 108 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
22d faster than avg
Panel avg: 130d · This submission: 108d
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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

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.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 58
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K182635.
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · H R Pharmaceuticals, Inc. · Mar 2020
Silicone Foley Catheter
K182463 · Biosensors International Pte, Ltd. · Nov 2019
Urethrotech UCD
K190060 · Urethrotech · Oct 2019
PSM 3-Way Silicone Foley Catheter
K181616 · Pathway, LLC · Sep 2018
Bard Vertus Foley Catheter
K180781 · C.R. Bard, Inc. · Sep 2018
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
K181814 · Amsino International, Inc. · Sep 2018