510(k) · Cleared
ClearedVaginal Tactile 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 May 28, 2015 as substantially equivalent to K031169 (Sierra Scientific Instruments, Inc., 2003) and 1 other predicate after a 276-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- May 28, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011472 (2001). 3 ancestors in all, the oldest K983052 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011472 Polygram 98 Anorectal Function Testing Application, Polygram 98…Medtronic Functional Diagnostics A/S · 2001
- 1 generation backK031169 Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003 · Recalled
- This deviceK142355 Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK231875 Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… | Medtronic Functional Diagnostics A/S | 2001 | — |
| −1 | K031169 | Motility Visualization System | Sierra Scientific Instruments, Inc. | 2003 | 1 |
| 0 (this device) | K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K031169 | Motility Visualization SystemSummary page 4…Perineometer Product Code: HIR Regulation Number: 884.1425 5.2. LEGALLY MARKETED DEVICES FOR SUBSTANTIAL EQUIVALENCE 1. K031169, Motility Visualization System (Sierra Scientific Instruments, Inc.) 2. K983052, Peritron Perineometer Model 9300V or 9300A (Card… | 2003 |
| * | K983052 | Peritron Perineometer Model 9300V or 9300ASummary page 4…884.1425 5.2. LEGALLY MARKETED DEVICES FOR SUBSTANTIAL EQUIVALENCE 1. K031169, Motility Visualization System (Sierra Scientific Instruments, Inc.) 2. K983052, Peritron Perineometer Model 9300V or 9300A (Cardio Design Pty. Ltd.) 5.3. DESCRIPTION The Vaginal Tactile Imager (VTI) obtain… | 1998 |
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 |
|---|---|---|---|
| K231875 | Vaginal Tactile Ultrasound Imager | 2024 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K231875 (Advanced Tactile Imaging, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K031169.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142355: Vaginal Tactile Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142355
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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