# K850247: Peritoneal Dialysis Coil Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Feb 14, 1985 after 23 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K961392: Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II (1997), 3 descendants of its own
- K012193: Amc Antimicrobial Pin/Wire Sleeve (2002), 2 descendants of its own
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own
- K022676: Orthoguard AB Antimicrobial Sleeve (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K850247
Methodology: https://510kreport.com/methodology