510(k) · Cleared
ClearedUnitip Gastrointestinal Pressure Sensor Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unisensor AG · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jul 31, 2001 after a 253-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 253 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK003580 Unitip Gastrointestinal Pressure Sensor CatheterUnisensor AG · 2001
- Descendant · cites it directly · 2 of its ownK062222 Unitip High Resolution CatheterUnisensor AG · 2007
- Descendant · 2 generations on · 0 of its ownK190208 Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK102801 Phtip Disposable Isfet CatheterE-Cath Co., Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See all- K062222Unitip High Resolution CatheterUnisensor AG · 2007 · cites it directly2descendants
- K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare · 2019 · 2 generations on0descendants
- K102801Phtip Disposable Isfet CatheterE-Cath Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003580 | Unitip Gastrointestinal Pressure Sensor Catheter | Unisensor AG | 2001 | — |
| +1 | K062222 | Unitip High Resolution Catheter | Unisensor AG | 2007 | — |
| +2 | K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | 2019 | 1 |
| +1 | K102801 | Phtip Disposable Isfet Catheter | E-Cath Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K062222 (Unisensor AG, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K003580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003580: Unitip Gastrointestinal Pressure Sensor Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003580
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026