510(k) · Cleared
ClearedEndoflip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crospon, Ltd. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Dec 15, 2009 as substantially equivalent to K991288 (G & J Electronics, Inc., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1999. 9 later devices descend from it.
- Decided
- Dec 15, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991288 (1999). 2 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK991288 Distender Series II BarostatG & J Electronics, Inc. · 1999
- This deviceK092850 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
- Descendant · cites it directly · 1 of its ownK102214 Endo FlipCrospon, Ltd. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K102214Endo FlipCrospon, Ltd. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +1 | K102214 | Endo Flip | Crospon, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 1…oring system Classification Name: FFX Device: EndoFLIP System and Catheter Predicate Devices: K99 1288 - G&J Electronics, Distender Series II Barostat K01 2232 - Sandhill Scientific, Insight Mode… | 1999 |
| * | K012232 | Insight, Model S980000Summary page 1…EndoFLIP System and Catheter Predicate Devices: K99 1288 - G&J Electronics, Distender Series II Barostat K01 2232 - Sandhill Scientific, Insight Model S980000 Device Description: The EndoFLIP& comprises a measuring system and a single use ca… | 2002 |
What descends from it? (9)
4 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?
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 EndoFLIP® system is an endoscopically-placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092850: Endoflip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092850
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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