510(k) · Cleared
ClearedPH Analysis Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synectics-Dantec · FFT Electrode, Ph, Stomach
Cleared on Jan 29, 1997 after a 320-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Jan 29, 1997
- Review
- 320 days
- Class
- Class I
- Product code
- FFT
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceK961346 PH Analysis ModuleSynectics-Dantec · 1997
- Descendant · cites it directly · 1 of its ownK981733 Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension…Medtronic Functional Diagnostics A/S · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK011471 Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile)…Medtronic Functional Diagnostics A/S · 2002
Most influential descendants
Showing 2 of 2 · See all- K981733Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111Medtronic Functional Diagnostics A/S · 1999 · cites it directly1descendant
- K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961346 | PH Analysis Module | Synectics-Dantec | 1997 | — |
| +1 | K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 | Medtronic Functional Diagnostics A/S | 1999 | 1 |
| +2 | K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber… | Medtronic Functional Diagnostics A/S | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 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 FFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K859361 | EsopHogram Software (DOS environment) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…use Synectics Medical AB Renstiernas gata 12 S-116 28 Stockholm Sweden Contact: Anna Pettersson pH Analysis Module EsopHogram Software (DOS environment) (included in K859361 - Synectics pH System Comprising Digitrapper Mark II, EsopHogram Software & Monocrystant Catheter) The Polygram Software for Win… | |
| † | K946322 | Polygram Software | 1995 |
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 |
|---|---|---|---|
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 | 1999 | 1 |
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, K981733 (Medtronic Functional Diagnostics A/S, 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FFT devicesFFT Electrode, Ph, Stomach: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · FFT
Too few FFT 510(k)s in any year since 2007 to give a median.
Recalls per year · FFT
1in 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FFT
590in 2025
MAUDE reports naming product code FFT, 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 | 0 | — | 1 | 499 |
| 2008 | 0 | — | 0 | 884 |
| 2009 | 0 | — | 0 | 336 |
| 2010 | 1 | — | 0 | 928 |
| 2011 | 0 | — | 0 | 1,506 |
| 2012 | 0 | — | 0 | 1,707 |
| 2013 | 0 | — | 0 | 314 |
| 2014 | 0 | — | 0 | 306 |
| 2015 | 0 | — | 0 | 347 |
| 2016 | 0 | — | 0 | 472 |
| 2017 | 0 | — | 0 | 896 |
| 2018 | 0 | — | 0 | 955 |
| 2019 | 0 | — | 0 | 621 |
| 2020 | 0 | — | 0 | 770 |
| 2021 | 0 | — | 0 | 516 |
| 2022 | 0 | — | 0 | 260 |
| 2023 | 0 | — | 0 | 259 |
| 2024 | 0 | — | 0 | 239 |
| 2025 | 0 | — | 0 | 590 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
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/K961346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961346: PH Analysis Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961346
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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