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 May 1, 2016 as substantially equivalent to K991288 (G & J Electronics, Inc., 1999) and 2 other predicates after a 46-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.
- Decided
- May 1, 2016
- Review
- 46 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K991288 (1999). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK991288 Distender Series II BarostatG & J Electronics, Inc. · 1999
- 2 generations backK092850 EndoflipCrospon, Ltd. · 2009
- 1 generation backK120997 Barostat Software OptionCrospon, Ltd. · 2012
- This deviceK160725 EndoFLIPCrospon, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK183072 EndoFLIP SystemCrospon, Ltd. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK223705 EndoflipTM 300Covidien, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK231861 EndoflipTM 300 SystemCovidien, LLC · 2023
- Descendant · cites it directly · 0 of its ownK170833 EndoFLIP® System with FLIP Topography moduleCrospon, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K183072EndoFLIP SystemCrospon, Ltd. · 2019 · cites it directly2descendants
- K223705EndoflipTM 300Covidien, LLC · 2023 · 2 generations on1descendant
- K231861EndoflipTM 300 SystemCovidien, LLC · 2023 · 3 generations on0descendants
- K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| −2 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| −1 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| 0 (this device) | K160725 | EndoFLIP | Crospon, Ltd. | 2016 | — |
| +1 | K183072 | EndoFLIP System | Crospon, Ltd. | 2019 | 1 |
| +2 | K223705 | EndoflipTM 300 | Covidien, LLC | 2023 | — |
| +3 | K231861 | EndoflipTM 300 System | Covidien, LLC | 2023 | — |
| +1 | K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991288 | Distender Series II BarostatSummary page 4…tility monitoring system Classification Name: FFX Device: EndoFLIP® System Predicate Device: K991288 – G&J Electronics, Distender Series II Barostat Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd.… | 1999 |
| * | K120997 | Barostat Software OptionSummary page 4…EndoFLIP® System Predicate Device: K991288 – G&J Electronics, Distender Series II Barostat Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd. K092850 – EndoFLIP® system – Crospon Ltd. Device Descript… | 2012 |
| * | K092850 | EndoflipSummary page 4…91288 – G&J Electronics, Distender Series II Barostat Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd. K092850 – EndoFLIP® system – Crospon Ltd. Device Description: The EndoFLIP® system and its accessory catheters are identical to the refe… | 2009 |
What descends from it? (4)
2 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K183072 (Crospon, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K991288.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It 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. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters…
Read the full statement (153 words)
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It 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.
The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.
Other indications for use include:
» To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters)
* For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)
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/K160725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160725: EndoFLIP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160725
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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