510(k) · Cleared
ClearedPC Polygraf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synectics-Dantec · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Mar 18, 1988 after a 252-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
- Mar 18, 1988
- Review
- 252 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK872712 PC PolygrafSynectics-Dantec · 1988
- Descendant · cites it directly · 1 of its ownK972439 Anorectal Manometry Analysis ModuleMedtronic-Synectics · 1997
- Descendant · cites it directly · 0 of its ownK992713 Polygraf ID, Polygram '98 Esophageal Manometry Testing Application…Medtronic Functional Diagnostics A/S · 1999
- Descendant · 2 generations on · 0 of its ownK991389 Anorectal Manometry Suite, Model 9032S0201Medtronic Functional Diagnostics A/S · 1999
Most influential descendants
Showing 3 of 3 · See all- K972439Anorectal Manometry Analysis ModuleMedtronic-Synectics · 1997 · cites it directly1descendant
- K992713Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models…Medtronic Functional Diagnostics A/S · 1999 · cites it directly0descendants
- K991389Anorectal Manometry Suite, Model 9032S0201Medtronic Functional Diagnostics A/S · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872712 | PC Polygraf | Synectics-Dantec | 1988 | — |
| +1 | K972439 | Anorectal Manometry Analysis Module | Medtronic-Synectics | 1997 | — |
| +1 | K992713 | Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models… | Medtronic Functional Diagnostics A/S | 1999 | — |
| +2 | K991389 | Anorectal Manometry Suite, Model 9032S0201 | Medtronic Functional Diagnostics A/S | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 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 KLA? 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 KLA device
- #1 K242666 Fecobionics Anorectal Systemscore 10.3 · 6 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, K972439 (Medtronic-Synectics, 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KLA devicesKLA Monitor, Esophageal Motility, Anorectal Motility, And Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLA
Too few KLA 510(k)s in any year since 2007 to give a median.
Recalls per year · KLA
No recall names KLA since 2007.
Adverse event reports per year · KLA
1in 2024
MAUDE reports naming product code KLA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K872712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K872712: PC Polygraf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872712
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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