# K962472: Rusch Urodynamic Rectal Balloon 2-Way Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Aug 27, 1996 after 63 days
- Product code: FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)
- Device class: 2
- Regulation: 21 CFR 876.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912451 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952573: Rusch Urodynamic Rectal Balloon Catheter, Rusch Intl. (1995). Our OCR of the scanned summary read K852573, FDA’s number for Technicon RA-1000 System Analyte Theophylline (Technicon Instruments Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rusch Urodynamic Rectal Balloon Catheter”. Summary page 2.
- K912451: Urodynamic Rectal Balloon, Cook Urological, Inc. (1991) Summary page 1.
- (no number) Porges Urodynamic Rectal Balloon Catheter: named in the summary without a submission number

## Recalls of this device
- Mar 15, 2018 · Class II · Z-1368-2018: These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

## Indications for use
The Rusch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.

Source page: https://510kreport.com/device/K962472
Methodology: https://510kreport.com/methodology