510(k) · Cleared
Recalled · Class II · 2018Rusch Urodynamic Rectal Balloon 2-Way Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Cleared on Aug 27, 1996 as substantially equivalent to K952573 (Rusch Intl., 1995) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Aug 27, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- FAP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912451 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912451 Urodynamic Rectal BalloonCook Urological, Inc. · 1991
- This deviceK962472 Rusch Urodynamic Rectal Balloon 2-Way CatheterRusch Intl. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912451 | Urodynamic Rectal Balloon | Cook Urological, Inc. | 1991 | — |
| 0 (this device) | K962472 | Rusch Urodynamic Rectal Balloon 2-Way Catheter | Rusch Intl. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952573 | Rusch Urodynamic Rectal Balloon Catheter 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”. | 1995 |
| * | K912451 | Urodynamic Rectal BalloonSummary page 1…Devices Rusch Urodynamic Rectal Balloon Catheter - K852573 Porges Urodynamic Rectal Balloon Catheter - Preamendment Cook Urological Urodynamic Rectal Balloon Catheter - K912451 4 Description of Device The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube u… | 1991 |
| * | — | Porges Urodynamic Rectal Balloon Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2018 | Class II | Z-1368-2018 | Employee error | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All FAP devicesFAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · FAP
Too few FAP 510(k)s in any year since 2007 to give a median.
Recalls per year · FAP
No recall names FAP since 2007.
Adverse event reports per year · FAP
36in 2025
MAUDE reports naming product code FAP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962472: Rusch Urodynamic Rectal Balloon 2-Way Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026