510(k) Report

510(k) · Cleared

Cleared

Polygram 98 Anorectal Function Testing Application, Model 9043S0111

K000386510(k) TraditionalCleared May 5, 200088-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 Functional Diagnostics A/S · FFX System, Gastrointestinal Motility (Electrical)

Cleared on May 5, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 5, 2000
Review
88 days
Class
Class II
Product code
FFX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK000386 Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/S · 2000
  2. Descendant · cites it directly · 0 of its ownK041244 Polygram Net Biofeedback ApplicationMedtronic Vascular · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K041244Polygram Net Biofeedback ApplicationMedtronic Vascular · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000386Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/S2000—
+1K041244Polygram Net Biofeedback ApplicationMedtronic Vascular2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K000386, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K041244Polygram Net Biofeedback ApplicationMedtronic Vascular20040

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, K041244 (Medtronic Vascular, 2004) 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

2007: 22008: 12009: 22010: 22012: 42013: 12016: 32017: 22018: 12019: 42020: 12023: 32024: 12025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFX

123in 2023

2012: 120 days median2016: 145 days median2019: 240 days median2023: 123 days median
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

2009: 12011: 12026 (partial year): 2
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

2009: 22010: 62011: 62012: 42013: 42014: 42015: 102016: 152017: 102018: 172019: 272020: 202021: 262022: 312023: 512024: 592025: 32
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
20092—12
20102—06
20110—16
2012412004
20131—04
20140—04
20150—010
20163145015
20172—010
20181—017
20194240027
20201—020
20210—026
20220—031
20233123051
20241—059
20251—032
20261—2—

More from Medtronic Functional Diagnostics A/S

11 FDA decisions under this applicant name. See the company

  • K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102Medtronic Functional Diagnostics A/S · 2002
  • K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S · 2002
  • K002992Disposable Hypodermic Needle Electrode, Model…Medtronic Functional Diagnostics A/S · 2001
  • K011472Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf IDMedtronic Functional Diagnostics A/S · 2001
  • K010130Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103Medtronic Functional Diagnostics A/S · 2001

Recent decisions in FFX

The FFX category page

  • K262621Rapid Barostat Bag (RBB) Pump and Catheter SystemMui Scientific, Inc. · 2026
  • K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
  • K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp. · 2024
  • K231861EndoflipTM 300 SystemCovidien, LLC · 2023
  • K223705EndoflipTM 300Covidien, LLC · 2023

https://510kreport.com/device/K000386 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000386: Polygram 98 Anorectal Function Testing Application, 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/K000386

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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