Cleared Traditional

K241946 - PeritX™ 1L Drainage Kit (90-1010) (FDA 510(k) Clearance)

Also includes:
PeritX™ 2L Drainage Kit (90-2010) PeritX™ Peritoneal Catheter Kit (50-9000C) PeritX™ Peritoneal Catheter and Starter Kit (50-9900C) PeritX™ Peritoneal Catheter Mini Kit (50-9050A) PleurX™ Low Profile Catheter Mini Kit (50-8050) Valve Cap (50-7235A) PeritX™ Valve Kit (50-7272) Catheter Access Kit (50-7280A) Lockable Drainage Line (50-7245A) Lockable Drainage Line Kit (50-7265A) PleurX™ Supplemental Insertion Kit (50-7262) Procedure Pack (50-

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

K241946 · Bard Peripheral Vascular, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
156d
Days
Class 2
Risk

K241946 is an FDA 510(k) clearance for the PeritX™ 1L Drainage Kit (90-1010). Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 6, 2024 after a review of 156 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 Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K241946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date December 06, 2024
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.
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.