PNG · Class II · 21 CFR 876.5630

FDA Product Code PNG: Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

Refractory ascites from liver cirrhosis or malignancy can be managed with long-term drainage systems. FDA product code PNG covers peritoneal drainage catheters for chronic ascites management.

These tunneled catheters are placed under ultrasound guidance to provide repeated ambulatory drainage of peritoneal fluid, allowing patients to drain ascites at home without repeated paracentesis visits. They improve quality of life in patients with malignant and refractory cirrhotic ascites.

PNG devices are Class II medical devices, regulated under 21 CFR 876.5630 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Care Fusion, Pfm Medical, Inc. and C.R. Bard, Inc..

15
Total
15
Cleared
161d
Avg days
2005
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 205d recently vs 154d historically

FDA 510(k) Cleared Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling Devices (Product Code PNG)

15 devices
1–15 of 15
Cleared Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
K241278
Pfm Medical, Inc.
Gastroenterology & Urology · 253d
Cleared Dec 06, 2024
PeritX™ 1L Drainage Kit (90-1010)
K241946
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 156d
Cleared Nov 24, 2023
Passio Pump Drainage System
K230319
Bearpac Medical
Gastroenterology & Urology · 291d
Cleared May 02, 2023
ASEPT Peritoneal Drainage System
K221779
Pfm Medical, Inc.
Gastroenterology & Urology · 315d
Cleared Dec 14, 2021
Aspira Peritoneal Drainage System
K212675
Merit Medical Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Oct 21, 2020
PleurX Peritoneal Catheter System
K201155
Care Fusion
Gastroenterology & Urology · 174d
Cleared Nov 14, 2016
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457
Rocket Medical Plc
Gastroenterology & Urology · 73d
Cleared Nov 03, 2016
PleurX Peritoneal Catheter System
K160437
Care Fusion
Gastroenterology & Urology · 260d
Cleared Mar 29, 2016
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
K152105
Rocket Medical Plc
Gastroenterology & Urology · 244d
Cleared Oct 24, 2012
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
K122422
Care Fusion
Gastroenterology & Urology · 76d
Cleared Mar 19, 2012
PLEURX PERITONEAL CATHETER SYSTEM
K113854
Care Fusion
Gastroenterology & Urology · 81d
Cleared May 06, 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
K110396
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 26, 2010
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796
Pfm Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 18, 2008
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288
C.R. Bard, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 15, 2005
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
K051711
Denver Biomedical, Inc.
Gastroenterology & Urology · 141d

About Product Code PNG - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code PNG since 2005, with 15 receiving FDA clearance (average review time: 161 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - PNG Product Code

Recent submissions under PNG have taken an average of 205 days to reach a decision - up from 154 days historically. Manufacturers should account for longer review timelines in current project planning.

PNG devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →