Cleared Traditional

K180485 - Argyle Peritoneal Dialysis Catheter and...

K180485 is an FDA 510(k) clearance for Argyle Peritoneal Dialysis Catheter and..., manufactured by Covidien, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K180485 · Covidien, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
154d
Days
Class 2
Risk

K180485 is an FDA 510(k) clearance for the Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Di.... Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on July 27, 2018 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Covidien, LLC devices

FDA 510(k) Submission Details - K180485

510(k) Number K180485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 23, 2018
Decision Date July 27, 2018
Days to Decision 154 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
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 19
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K180485.
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
K213602 · Covidien, LLC · Jan 2022
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
K121383 · Medical Components, Inc. · Sep 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354 · Pfm Medical, Inc. · Mar 2012
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · Sil-Med Corp. · Jul 1997
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490 · Medical Components, Inc. · Feb 1994
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990