# K970021: Rusch Suprapubic Tray

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Feb 7, 1997 after 35 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rusch SupraFoley Suprapubic Introducer and Foley Catheter: named in the summary without a submission number
- (no number) Rusch Simplastic Suprapubic Catheter: named in the summary without a submission number
- (no number) Microvasive Percutaneous Suprapubic Balloon Catheter Set: named in the summary without a submission number
- (no number) Cook Stamey Percutaneous Catheter Set: named in the summary without a submission number
- (no number) Rusch Suprapubic Catheters: named in the summary without a submission number

## Most influential descendants
- K132890: Suprapubic Catheter and Introducer Set (2014), 1 descendant of its own
- K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (2018), 0 descendants of its own
- K102572: Iyunni 3ID Suprapubic Cystostomy Tube Kit (2010), 0 descendants of its own

## Indications for use
The kit is used for percutaneous bladder drainage and to drain fiuids to and from the urinary tract.

Source page: https://510kreport.com/device/K970021
Methodology: https://510kreport.com/methodology