510(k) · Cleared
ClearedEndoflipTM 300 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jul 21, 2023 as substantially equivalent to K223705 (Covidien, LLC, 2023) after a 28-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jul 21, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991288 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK991288 Distender Series II BarostatG & J Electronics, Inc. · 1999
- 5 generations backK092850 EndoflipCrospon, Ltd. · 2009
- 4 generations backK120997 Barostat Software OptionCrospon, Ltd. · 2012
- 3 generations backK160725 EndoFLIPCrospon, Ltd. · 2016
- 2 generations backK183072 EndoFLIP SystemCrospon, Ltd. · 2019 · Recalled
- 1 generation backK223705 EndoflipTM 300Covidien, LLC · 2023
- This deviceK231861 EndoflipTM 300 SystemCovidien, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| −5 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| −4 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| −3 | K160725 | EndoFLIP | Crospon, Ltd. | 2016 | — |
| −2 | K183072 | EndoFLIP System | Crospon, Ltd. | 2019 | 1 |
| −1 | K223705 | EndoflipTM 300 | Covidien, LLC | 2023 | — |
| 0 (this device) | K231861 | EndoflipTM 300 System | Covidien, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (1)
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 |
|---|---|---|---|
| * | K223705 | EndoflipTM 300Summary page 4…Regulatory Class: II Product Code: FFX III. PREDICATE DEVICE Predicate Name: EndoflipTM 300 System Predicate 510(k) number: K223705 IV. DEVICE DESCRIPTION The subject EndoflipTM 300 System is HTXLYDOHQW to the predicate EndoflipTM 300 System (K223705) except f… | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from five years of age. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231861: EndoflipTM 300 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231861
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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