510(k) · Cleared

Cleared

Anorectal Manometry Analysis Module

K972439510(k) TraditionalCleared Sep 23, 199785-day reviewClass II21 CFR 876.1725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic-Synectics · FFX System, Gastrointestinal Motility (Electrical)

Cleared on Sep 23, 1997 as substantially equivalent to K872712 (Synectics-Dantec, 1988) after an 85-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided: Sep 23, 1997
Review: 85 days
Class: Class II
Product code: FFX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872712 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK872712 PC PolygrafSynectics-Dantec · 1988
This deviceK972439 Anorectal Manometry Analysis ModuleMedtronic-Synectics · 1997
Descendant · cites it directly · 0 of its ownK991389 Anorectal Manometry Suite, Model 9032S0201Medtronic Functional Diagnostics A/S · 1999

Most influential descendants

Showing 1 of 1 · See all

K991389Anorectal Manometry Suite, Model 9032S0201Medtronic Functional Diagnostics A/S · 1999 · cites it directly0descendants

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)	K972439	Anorectal Manometry Analysis Module	Medtronic-Synectics	1997	—
+1	K991389	Anorectal Manometry Suite, Model 9032S0201	Medtronic Functional Diagnostics A/S	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K972439, 1988–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K872712	PC Polygraf Summary page 1 …78 Contact: Anna Pettersson Contact: Keith Jung Name of device Anorectal Manometry Analysis Module Name of Polygram Software (DOS environment) equivalent (included in 872712 - Polygraf) device The Anorectal Analysis Module is identical, in function and types of analyses that can be performed, to the P…	Synectics-Dantec	1988	—
†	K946322	Polygram Software	Synectics Medical, Inc.	1995	—

Also cleared against K872712: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K991389	Anorectal Manometry Suite, Model 9032S0201	Medtronic Functional Diagnostics A/S	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K991389 (Medtronic Functional Diagnostics A/S, 1999) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K872712.

How does its category compare?

All FFX devices

FFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFX

1in 2025

2007high 4 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFX

123in 2023

2007high 240 (2019) · low 120 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FFX

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FFX

32in 2025

2007high 59 (2024) · low 0 (2007)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 Anorectal Analysis Module is a suflware program that has been designed to analyse pressure duta recorded from the lower gastrointestinal tract in pediatric and adult populations.

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/K972439 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972439: Anorectal Manometry Analysis Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972439

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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