510(k) · Cleared
ClearedPolygram Net Biofeedback Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · HCC Device, Biofeedback
Cleared on Aug 12, 2004 as substantially equivalent to K000386 (Medtronic Functional Diagnostics A/S, 2000) and 2 other predicates after a 93-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 12, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000386 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000386 Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/S · 2000
- This deviceK041244 Polygram Net Biofeedback ApplicationMedtronic Vascular · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111 | Medtronic Functional Diagnostics A/S | 2000 | — |
| 0 (this device) | K041244 | Polygram Net Biofeedback Application | Medtronic Vascular | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111Summary page 1…application Classification Name: Gastrointestinal motility monitoring system Name of Predicate Device POLYGRAM Anorectal Functional Testing Application, K000386 Regain Desktop, K003127 Orion Platinum, K003367 Device Description… | 2000 |
| * | K003127 | Regain DesktopSummary page 1…stinal motility monitoring system Name of Predicate Device POLYGRAM Anorectal Functional Testing Application, K000386 Regain Desktop, K003127 Orion Platinum, K003367 Device Description The POLYGRAM NETTM Biofeedback Application is used to… | 2001 |
| * | K003367 | Orion PlatinumSummary page 1…evice POLYGRAM Anorectal Functional Testing Application, K000386 Regain Desktop, K003127 Orion Platinum, K003367 Device Description The POLYGRAM NETTM Biofeedback Application is used to assess and treat pelvic floor dysfunction. Data is co… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The POLYGRAM NET Biofeedback Application is intended for the assessment and treatment of pelvic floor dysfunction through biofeedback in patients 4 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041244 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041244: Polygram Net Biofeedback Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041244
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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