# K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Oct 24, 2012 after 76 days
- Product code: PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932323 (1993). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113854: Pleurx Peritoneal Catheter System, Care Fusion (2012) Summary page 4.
- K110396: Aspira Peritoneal Drainage System, C.R. Bard, Inc. (2011) Summary page 4.
- K090394: Valved Tearway Introducer, Medcomp (2009). Our OCR of the scanned summary read K080394, FDA’s number for Blackstone Ascent Posterior Occipital Cervico-Thoracic… (Blackstone Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Martech (MEDCOMP) Valved Tearaway Introducer”.
- K040150: Modification to Medamicus Flowguard Peelable Introducer, Medamicus, Inc. (2004) Summary page 4.

## Most influential descendants
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own
- K201155: PleurX Peritoneal Catheter System (2020), 1 descendant of its own
- K241946: PeritX™ 1L Drainage Kit (90-1010); 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- (2024), 0 descendants of its own
- K170405: BD Curve Ascites Shunt (2017), 0 descendants of its own

## Indications for use
The Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only. The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage. The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site. The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance. The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space. The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.

Source page: https://510kreport.com/device/K122422
Methodology: https://510kreport.com/methodology