# K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Sep 5, 2012 after 120 days
- Product code: FJS (Catheter, Peritoneal, 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: 10 generations back to K001901 (2000). 54 ancestors in all.
No later device cites it as a predicate yet.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560, Medigroup, Inc. (2007) Summary page 1.
- K950042: Swan Neck Presternal Peritoneal Dialysis Catheter, Accurate Surgical Instruments Co. (1995) Summary page 1.
- K915490: Medcomp Peritoneal Dialysis Catheters, Medical Components, Inc. (1994) Summary page 1.
- K113487: Hemo-Cath 10F, Hemo-Cath 12.5F, Medical Components, Inc. (2012) Summary page 1.
- K110424: Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil, Medcomp ( Medical Components) (2011) Summary page 1.

## Indications for use
The 'X' Series Catheter is indicated for chronic peritoneal dialysis. The extended length of the 'X' Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.

Source page: https://510kreport.com/device/K121383
Methodology: https://510kreport.com/methodology