510(k) · Cleared
ClearedEndoflip Catheter
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 Jul 17, 2013 as substantially equivalent to K092850 (Crospon, Ltd., 2009) and 3 other predicates after a 107-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jul 17, 2013
- Review
- 107 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K934084 (1993). 12 ancestors in all, the oldest K810156 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK934084 Bioenterics Endolumina Illuminating BougieBioenterics Corp. · 1993
- 2 generations backK960173 Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996
- 1 generation backK983220 Stryker Infravision Esophageal KitStryker Endoscopy · 1999 · Recalled
- This deviceK130906 Endoflip CatheterCrospon, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934084 | Bioenterics Endolumina Illuminating Bougie | Bioenterics Corp. | 1993 | — |
| −2 | K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal Kit | Gabriel Medical, Inc. | 1996 | — |
| −1 | K983220 | Stryker Infravision Esophageal Kit | Stryker Endoscopy | 1999 | 2 |
| 0 (this device) | K130906 | Endoflip Catheter | Crospon, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K092850 | EndoflipSummary page 1…/ CFR: FFX / CER 876.1725 / Class 2 Device: EndoFLIP® System and Catheter Predicate Devices: K092850 - Crospon - EndoFLIP® K 102214 -Crospon - EndoFLIP®… | 2009 |
| * | K102214 | Endo FlipSummary page 1…EndoFLIP® System and Catheter Predicate Devices: K092850 - Crospon - EndoFLIP® K 102214 -Crospon - EndoFLIP® K120997 - Crospon - EndoELIP®… | 2010 |
| * | K120997 | Barostat Software OptionSummary page 1…ices: K092850 - Crospon - EndoFLIP® K 102214 -Crospon - EndoFLIP® K120997 - Crospon - EndoELIP® K983220 - Stryker - lnfraVisionTM Device Description: The EndoFLI… | 2012 |
| * | K983220 | Stryker Infravision Esophageal KitSummary page 1…K 102214 -Crospon - EndoFLIP® K120997 - Crospon - EndoELIP® K983220 - Stryker - lnfraVisionTM Device Description: The EndoFLIP® comprises a measuring system and a single use or reusable catheter t… | 1999 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K092850.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 EndoFLIP6 system is an endoscopically placed device indicated for use in patients finted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting. EndoFLIPS EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves. The EndoFLIPO system is indicated for use…
Read the full statement (140 words)
The EndoFLIP6 system is an endoscopically placed device indicated for use in patients finted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.
EndoFLIPS EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EndoFLIPO system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130906: Endoflip Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130906
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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