# K120127: Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Swan Valley Medical, Incorporated
- Decided: Oct 26, 2012 after 283 days
- Product code: KOB (Catheter, Suprapubic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944355 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071459: B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes, B.Braun Medical, Inc. (2007) Summary page 3.

## Cited in the summary but kept off the family tree
- K010204: Stryker Navigation System-Knee Module, Stryker Corp. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642, Bio-Rad (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K983367: Qlicksmart, Handren Assoc. (1998). Our reading of the summary gave K983367, FDA’s number for Qlicksmart (Handren Assoc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BladeFLASK and BladeSINGLE”. Kept off the family tree. Summary page 3.

## Indications for use
The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeCe) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.

Source page: https://510kreport.com/device/K120127
Methodology: https://510kreport.com/methodology