510(k) · Cleared
ClearedVaginal Tactile Ultrasound Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Tactile Imaging, Inc. · HIR Perineometer
Cleared on Feb 22, 2024 as substantially equivalent to K142355 (Advanced Tactile Imaging, Inc., 2015) after a 241-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Feb 22, 2024
- Review
- 241 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011472 (2001). 4 ancestors in all, the oldest K983052 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK011472 Polygram 98 Anorectal Function Testing Application, Polygram 98…Medtronic Functional Diagnostics A/S · 2001
- 2 generations backK031169 Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003 · Recalled
- 1 generation backK142355 Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc. · 2015
- This deviceK231875 Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… | Medtronic Functional Diagnostics A/S | 2001 | — |
| −2 | K031169 | Motility Visualization System | Sierra Scientific Instruments, Inc. | 2003 | 1 |
| −1 | K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | 2015 | — |
| 0 (this device) | K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K142355 | Vaginal Tactile ImagerSummary page 6…system Product Code: HIR/IYO Regulation Number: 884.1425/892.1560 2. LEGALLY MARKETED DEVICES FOR SUBSTANTIAL EQUIVALENCE 1. K142355, Vaginal Tactile Imager (Advanced Tactile Imaging, Inc.), 3. DESCRIPTION The Vaginal Tactile Ultrasound Imager (TIUSv) acquires… | 2015 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231875: Vaginal Tactile Ultrasound Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231875
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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