# K102572: Iyunni 3ID Suprapubic Cystostomy Tube Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sainath Intellectual Properties, LLC
- Decided: Dec 27, 2010 after 110 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915841 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit, Sainath Intellectual Properties, LLC (2009) Summary page 1.
- K970021: Rusch Suprapubic Tray, Rusch, Inc. (1997) Summary page 1.
- K952187: Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile, Rusch, Inc. (1995) Summary page 1.

## Indications for use
The IYUNN T m 31D Supvapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.

Source page: https://510kreport.com/device/K102572
Methodology: https://510kreport.com/methodology