510(k) · Cleared
ClearedDistender Series II Barostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G & J Electronics, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jun 8, 1999 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Jun 8, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK991288 Distender Series II BarostatG & J Electronics, Inc. · 1999
- Descendant · cites it directly · 9 of its ownK092850 EndoflipCrospon, Ltd. · 2009
- Descendant · cites it directly · 7 of its ownK120997 Barostat Software OptionCrospon, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK160725 EndoFLIPCrospon, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK183072 EndoFLIP SystemCrospon, Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK223705 EndoflipTM 300Covidien, LLC · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092850EndoflipCrospon, Ltd. · 2009 · cites it directly9descendants
- K120997Barostat Software OptionCrospon, Ltd. · 2012 · cites it directly7descendants
- K160725EndoFLIPCrospon, Ltd. · 2016 · cites it directly4descendants
- K183072EndoFLIP SystemCrospon, Ltd. · 2019 · 2 generations on2descendants
- K223705EndoflipTM 300Covidien, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| +1 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| +1 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| +1 | K160725 | EndoFLIP | Crospon, Ltd. | 2016 | — |
| +2 | K183072 | EndoFLIP System | Crospon, Ltd. | 2019 | 1 |
| +3 | K223705 | EndoflipTM 300 | Covidien, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K092850 (Crospon, Ltd., 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 G&J Elactronics Distender Series || Dual Drive Barostal device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991288: Distender Series II Barostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991288
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