510(k) · Cleared
ClearedPolygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Functional Diagnostics A/S · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Aug 10, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Aug 10, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK011472 Polygram 98 Anorectal Function Testing Application, Polygram 98…Medtronic Functional Diagnostics A/S · 2001
- Descendant · cites it directly · 15 of its ownK031169 Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 3 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · 2 generations on · 2 of its ownK062222 Unitip High Resolution CatheterUnisensor AG · 2007
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K031169Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003 · cites it directly15descendants
- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · 2 generations on7descendants
- K161785THD AnopressThd Spa · 2017 · 3 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 3 generations on3descendants
- K062222Unitip High Resolution CatheterUnisensor AG · 2007 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… | Medtronic Functional Diagnostics A/S | 2001 | — |
| +1 | K031169 | Motility Visualization System | Sierra Scientific Instruments, Inc. | 2003 | 1 |
| +2 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +3 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +3 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +2 | K062222 | Unitip High Resolution Catheter | Unisensor AG | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (16)
See all 162 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, K031169 (Sierra Scientific Instruments, Inc., 2003) has gone furthest, with 15 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/K011472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011472
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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