510(k) · Cleared
ClearedRapid Barostat Bag (RBB) Pump and Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mui Scientific · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Mar 14, 2017 as substantially equivalent to K991288 (G & J Electronics, Inc., 1999) and 1 other predicate after a 405-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Mar 14, 2017
- Review
- 405 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973844 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973844 Gastric and Rectal CathetersG & J Electronics, Inc. · 1999
- This deviceK160287 Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific · 2017
- Descendant · cites it directly · 0 of its ownK262621 Rapid Barostat Bag (RBB) Pump and Catheter SystemMui Scientific, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262621Rapid Barostat Bag (RBB) Pump and Catheter SystemMui Scientific, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973844 | Gastric and Rectal Catheters | G & J Electronics, Inc. | 1999 | — |
| 0 (this device) | K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K991288 | Distender Series II BarostatSummary page 5…ing equivalence to the following predicates: Product Name 510(k) Number Manufacturer Distender Series II Barostat K991288 G&J Electronics Barostat Catheters K973844 M… | 1999 |
| * | K973844 | Gastric and Rectal CathetersSummary page 5…Manufacturer Distender Series II Barostat K991288 G&J Electronics Barostat Catheters K973844 Mui Scientific Substantial Equivalence for RBB Pump: The Distender Series II Barostat… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System | 2026 | 0 |
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?
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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/K160287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160287: Rapid Barostat Bag (RBB) Pump and Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160287
Report an extraction error
Are you the manufacturer?
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