510(k) · Cleared
Recalled · Class II · 2026EndoFLIP System
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 Feb 15, 2019 as substantially equivalent to K160725 (Crospon, Ltd., 2016) after a 102-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 15, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- FFX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991288 (1999). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK991288 Distender Series II BarostatG & J Electronics, Inc. · 1999
- 3 generations backK092850 EndoflipCrospon, Ltd. · 2009
- 2 generations backK120997 Barostat Software OptionCrospon, Ltd. · 2012
- 1 generation backK160725 EndoFLIPCrospon, Ltd. · 2016
- This deviceK183072 EndoFLIP SystemCrospon, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK223705 EndoflipTM 300Covidien, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK231861 EndoflipTM 300 SystemCovidien, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| −3 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| −2 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| −1 | K160725 | EndoFLIP | Crospon, Ltd. | 2016 | — |
| 0 (this device) | K183072 | EndoFLIP System | Crospon, Ltd. | 2019 | — |
| +1 | K223705 | EndoflipTM 300 | Covidien, LLC | 2023 | — |
| +2 | K231861 | EndoflipTM 300 System | Covidien, LLC | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K160725 | EndoFLIPSummary page 4…Product Code: FFX: System, Gastrointestinal Motility (Electrical) III. PREDICATE DEVICE(S) Endoflip System K160725 IV. DEVICE DESCRIPTION There is no change between the Predicate device (K160725) and Endoflip System. The Endoflip Sys… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223705 | EndoflipTM 300 | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2026 | Class II | Z-2950-2026 | Under Investigation by firm | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K223705 (Covidien, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160725.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 in adults and to measure pressure and dimensions in the esophagus, in patients from 5 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/K183072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183072: EndoFLIP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183072
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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