# K961194: Antimicrobial Mediastinal Silicone Drain

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Aug 8, 1996 after 134 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
Longest line of descent: 1 generation back to K900263 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942709: Mediastinal Silicone Drains, Sil-Med Corp. (1996) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.

## Indications for use
Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus

Source page: https://510kreport.com/device/K961194
Methodology: https://510kreport.com/methodology