# K041244: Polygram Net Biofeedback Application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 12, 2004 after 93 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000386 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000386: Polygram 98 Anorectal Function Testing Application, Model 9043S0111, Medtronic Functional Diagnostics A/S (2000) Summary page 1.
- K003127: Regain Desktop, Srs Medical Systems, Inc. (2001) Summary page 1.
- K003367: Orion Platinum, Srs Medical Systems, Inc. (2001) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K041244
Methodology: https://510kreport.com/methodology