# K942709: Mediastinal Silicone Drains

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Jan 4, 1996 after 575 days
- Product code: GBW (Catheter, Peritoneal)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K961295: Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar (1996), 1 descendant of its own
- K063245: Elutia  Coated Closed Surgical Wound Drain (2007), 0 descendants of its own
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K942709
Methodology: https://510kreport.com/methodology