510(k) · Cleared
ClearedPerineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · HIR Perineometer
Cleared on Aug 11, 1997 as substantially equivalent to K902843 (Biosearch Medical Products, Inc., 1990) and 1 other predicate after a 208-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 11, 1997
- Review
- 208 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902843 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902843 Biosearch Anal Biofeedback DeviceBiosearch Medical Products, Inc. · 1990
- This deviceK970145 Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal…Biosearch Medical Products, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902843 | Biosearch Anal Biofeedback Device | Biosearch Medical Products, Inc. | 1990 | — |
| 0 (this device) | K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe) | Biosearch Medical Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K902843 | Biosearch Anal Biofeedback DeviceSummary page 3…eedback monitor which will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (k902843) and (k813736) except that in this case we are inflating the balloon to provide gentie pressure to the vaginal wall. This will al… | 1990 |
| * | K913736 | Dobbhoff Anorect Biofeed Syst Five Div Fecal ConstSummary page 5…een removed.) to the Anorectal probe which has been previously approved via the following Biosearch Medical Products 510(k)'s : k902843 (System #5 & Anorectal Probe) and k913736 (System #10 & Anorectal Probe). *) LUER LOCK CONNECTOR -> (Not inserted into a body cavity) The material used is a Medical grade… | 1992 |
| † | K945611 | Peritron | 1996 |
| † | K862410 | Milex Kegel Perineal Exerciser | 1986 |
| † | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | 1989 |
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 2 ancestors has a recall.
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?
The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.
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/K970145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970145: Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970145
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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