# K823331: PC-204 Tunnelor

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup
- Decided: Jan 26, 1983 after 79 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 (2007), 2 descendants of its own
- K060897: Embedding Tool, Model TE-1000 (2006), 1 descendant of its own
- K213602: Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (2022), 0 descendants of its own
- K180485: Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender (2018), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K823331
Methodology: https://510kreport.com/methodology