510(k) · Cleared
ClearedPolygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101
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 10, 1999 as substantially equivalent to K872712 (Synectics-Dantec, 1988) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 10, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K872712 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872712 PC PolygrafSynectics-Dantec · 1988
- This deviceK992713 Polygraf ID, Polygram '98 Esophageal Manometry Testing Application…Medtronic Functional Diagnostics A/S · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872712 | PC Polygraf | Synectics-Dantec | 1988 | — |
| 0 (this device) | K992713 | Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models… | Medtronic Functional Diagnostics A/S | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K872712 | PC PolygrafSummary page 1…ication FFX 3. Predicate Device Identification: The functionality and intended use of the Esophageal Manometry System 1s equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070). 4. Device Description: Th… | 1988 |
| * | K946322 | Polygram SoftwareSummary page 1…The functionality and intended use of the Esophageal Manometry System 1s equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070). 4. Device Description: The system is a stationary manometry system for use… | 1995 |
| * | K961070 | Esophageal Manometry Analysis ModuleSummary page 1…al Manometry System 1s equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070). 4. Device Description: The system is a stationary manometry system for use in evaluating the function of the gastrointestinal… | 1996 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K872712.
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 Esophageal Manometry System is intended to record, store, view and analyze data on
line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
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/K992713 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992713: Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992713
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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