Cleared Traditional

K121383 - PS X SERIES (BASIC COMPONENTS AND CATHETER)

K121383 is an FDA 510(k) clearance for PS X SERIES (BASIC COMPONENTS AND CATHETER), manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K121383 · Medical Components, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2012
Decision
120d
Days
Class 2
Risk

K121383 is an FDA 510(k) clearance for the PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL C.... Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 5, 2012 after a review of 120 days - within the typical 510(k) review window.

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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K121383

510(k) Number K121383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 08, 2012
Decision Date September 05, 2012
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
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 18
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K121383.
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
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K180485 · Covidien, LLC · Jul 2018
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
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PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989