510(k) · Cleared
ClearedBilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober
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 Nov 8, 2002 as substantially equivalent to K981733 (Medtronic Functional Diagnostics A/S, 1999) after a 543-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Nov 8, 2002
- Review
- 543 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913387 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK913387 Digitrapper Mark IiiSynectics-Dantec · 1991
- 1 generation backK981733 Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension…Medtronic Functional Diagnostics A/S · 1999 · Recalled
- This deviceK011471 Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile)…Medtronic Functional Diagnostics A/S · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913387 | Digitrapper Mark Iii | Synectics-Dantec | 1991 | — |
| −1 | K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 | Medtronic Functional Diagnostics A/S | 1999 | 1 |
| 0 (this device) | K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber… | Medtronic Functional Diagnostics A/S | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111Summary page 1…functionality and intended use of the Polygram 98 pH Testing System (incl. bile) is equivalent to Medtronic Functional Diagnostics A/S’s Polygram 98 pH Testing System (K 981733). K011471 43511 Polygram 98 pH Testing System (incl. bile) 4. Device Description: The system is an ambulatory… | 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 11 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has 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.
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 Polygram 98 pH Testing System is intended to record, store, view and
analyze esophageal and gastric refluxate data to diagnose reflux disorders. The
Polygram 98 pH Testing System can also be used to locate the position of the
proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the
accurate placement of the pH catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011471: Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011471
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026