510(k) · Cleared
ClearedRapid Barostat Bag (RBB) Pump and Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mui Scientific, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Sep 30, 2026 as substantially equivalent to K160287 (Mui Scientific, 2017) after a 64-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Sep 30, 2026
- Review
- 64 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973844 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973844 | Gastric and Rectal Catheters | G & J Electronics, Inc. | 1999 | — |
| −1 | K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017 | — |
| 0 (this device) | K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System | Mui Scientific, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 FFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FFX device
- #1 K252605 mcompass Anorectal Balloon Expulsion Catheter…score 11.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K160287 | Rapid Barostat Bag (RBB) Pump and CatheterSummary page 5…tion Number: 21 CFR § 876.1725 Regulation Name: Gastrointestinal motility monitoring system. Product code: FFX Device Class: II Predicate Submission Number: K160287 Predicate Trade Name: Rapid Barostat Bag (RBB) Pump and Catheter Indications for Use: The Rapid Barostat Bag Pump and C… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.
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/K262621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262621: Rapid Barostat Bag (RBB) Pump and Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262621
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026