Cleared Traditional

K031351 - FLEX-NECK PD CATHETER, INFANT

K031351 is an FDA 510(k) clearance for FLEX-NECK PD CATHETER, manufactured by Medigroup, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K031351 · Medigroup, Inc. · Gastroenterology & Urology device
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Sep 2003
Decision
141d
Days
Class 2
Risk

K031351 is an FDA 510(k) clearance for the FLEX-NECK PD CATHETER, INFANT. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Medigroup, Inc. (Naperville, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 141 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 Medigroup, Inc. devices

FDA 510(k) Submission Details - K031351

510(k) Number K031351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date September 17, 2003
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
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 30
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K031351.
FLEX-NECK ARC CATHETER
K070730 · Medigroup, Inc. · Jul 2007
EMBEDDING TOOL, MODEL TE-1000
K060897 · Medigroup, Inc. · Jul 2006
PD CATH
K053123 · Med-Conduit, Inc. · Mar 2006
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · Medionics International, Inc. · Apr 2000
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · Janin Group, Inc. · Jun 1999
FLEX-NECK PD CATHETER
K970159 · Janin Group, Inc. · Sep 1997