510(k) · Cleared
ClearedPathway Vaginal/Rectal Perineometer Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Prometheus Group · HIR Perineometer
Cleared on Dec 22, 1997 as substantially equivalent to K911190 (Perrymeter Systems, 1991) after a 59-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Dec 22, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911190 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK911190 Perrymeter (TM)Perrymeter Systems · 1991
- This deviceK974036 Pathway Vaginal/Rectal Perineometer ProbeThe Prometheus Group · 1997
- Descendant · cites it directly · 0 of its ownK993976 Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim…The Prometheus Group · 2000
Most influential descendants
Showing 1 of 1 · See all- K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911190 | Perrymeter (TM) | Perrymeter Systems | 1991 | — |
| 0 (this device) | K974036 | Pathway Vaginal/Rectal Perineometer Probe | The Prometheus Group | 1997 | — |
| +1 | K993976 | Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim… | The Prometheus Group | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIR? 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 HIR device
- #1 K252748 Pelvic Floor Exerciser (PF01)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K911190 | Perrymeter (TM)Summary page 2…PREDICATE DEVICE The device to which we claim substantial equivalence is the Perrymeter Vaginal Perineometer Probe and Perrymeter Anal Perineometer Probe 510(k) number K911190/A. The Perrymeter probes are also single-user plastic probes with three metal electrode contacts. DESCRIPTION OF BEVICE The Pat… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993976 | Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor | 2000 | 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?
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIR
187in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIR
No recall names HIR since 2007.
Adverse event reports per year · HIR
1in 2024
MAUDE reports naming product code HIR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 3 | 29 | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 187 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Urinary Incontinence : Stress, Urge and Mixed Incontinence
Fecal Incontinence
Neuromuscular Reeducation
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974036: Pathway Vaginal/Rectal Perineometer Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974036
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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