# K031351: Flex-Neck PD Catheter, Infant

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup, Inc.
- Decided: Sep 17, 2003 after 141 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970159 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970159: Flex-Neck PD Catheter, Janin Group, Inc. (1997)

## Most influential descendants
- K070730: Flex-Neck Arc Catheter (2007), 0 descendants of its own

## Recalls of this device
- Sep 20, 2017 · Class II · Z-1144-2018: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
- Sep 20, 2017 · Class II · Z-1143-2018: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
- Sep 20, 2017 · Class II · Z-1145-2018: 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

## Indications for use
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck catheters, the Flex-Neck Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

Source page: https://510kreport.com/device/K031351
Methodology: https://510kreport.com/methodology