510(k) · Cleared

Recalled · 2004

Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111

K981733510(k) TraditionalCleared Feb 4, 1999262-day reviewClass II21 CFR 876.1725Recalls 1

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

Medtronic Functional Diagnostics A/S · FFX System, Gastrointestinal Motility (Electrical)

Cleared on Feb 4, 1999 as substantially equivalent to K913387 (Synectics-Dantec, 1991) and 2 other predicates after a 262-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled once.

Decided: Feb 4, 1999
Review: 262 days
Class: Class II
Product code: FFX
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K913387 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK913387 Digitrapper Mark IiiSynectics-Dantec · 1991
This deviceK981733 Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension…Medtronic Functional Diagnostics A/S · 1999
Descendant · cites it directly · 0 of its ownK011471 Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile)…Medtronic Functional Diagnostics A/S · 2002

Most influential descendants

Showing 1 of 1 · See all

K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913387	Digitrapper Mark Iii	Synectics-Dantec	1991	—
0 (this device)	K981733	Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111	Medtronic Functional Diagnostics A/S	1999	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K981733, 1991–2002Source: 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? (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	Applicant	Decided	Recalls
*	K913387	Digitrapper Mark Iii Summary page 1 …21 CFR 876.1400 3. Predicate Device Identification: The functionality and intended use of the pH Testing System is equivalent to Medtronic Synectics Digitrapper MK Il (K913387) with Polygram for Windows, Base Module (K946322) and EsopHogram reflux Analysis (K961346). 510(k) Notification p…	Synectics-Dantec	1991	—
*	K946322	Polygram Software Summary page 1 …on: The functionality and intended use of the pH Testing System is equivalent to Medtronic Synectics Digitrapper MK Il (K913387) with Polygram for Windows, Base Module (K946322) and EsopHogram reflux Analysis (K961346). 510(k) Notification pH Testing System 4. Device Description: The pH…	Synectics Medical, Inc.	1995	—
*	K961346	PH Analysis Module Summary page 1 …f the pH Testing System is equivalent to Medtronic Synectics Digitrapper MK Il (K913387) with Polygram for Windows, Base Module (K946322) and EsopHogram reflux Analysis (K961346). 510(k) Notification pH Testing System 4. Device Description: The pH Testing System consists of a general purp…	Synectics-Dantec	1997	—

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
K011471	Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober	Medtronic Functional Diagnostics A/S	2002	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 28, 2004	Not classified	Z-0924-04	Other	Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K011471 (Medtronic Functional Diagnostics A/S, 2002) has gone furthest, with 0 descendants of its own.

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 pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH 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/K981733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981733: Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981733

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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