510(k) · Cleared
ClearedGsa Genito Sensory Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medoc Ltd. Advanced Medical Systems · LLN Device, Vibration Threshold Measurement
Cleared on Sep 20, 2001 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 20, 2001
- Review
- 171 days
- Class
- Class I
- Product code
- LLN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK010981 Gsa Genito Sensory AnalyzerMedoc Ltd. Advanced Medical Systems · 2001
- Descendant · cites it directly · 2 of its ownK041908 Contact Heat-Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- Descendant · 2 generations on · 1 of its ownK051448 Modified Contact-Heat Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- Descendant · 3 generations on · 0 of its ownK052357 Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006
Most influential descendants
Showing 3 of 3 · See all- K041908Contact Heat-Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005 · cites it directly2descendants
- K051448Modified Contact-Heat Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005 · 2 generations on1descendant
- K052357Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010981 | Gsa Genito Sensory Analyzer | Medoc Ltd. Advanced Medical Systems | 2001 | — |
| +1 | K041908 | Contact Heat-Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| +2 | K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| +3 | K052357 | Pathway - Ats/Cheps | Medoc Ltd. Advanced Medical Systems | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041908 | Contact Heat-Evoked Potential Stimulator (Cheps) | 2005 | 2 |
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?
- Of its descendants, K041908 (Medoc Ltd. Advanced Medical Systems, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LLN devicesLLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LLN
Too few LLN 510(k)s in any year since 2007 to give a median.
Recalls per year · LLN
No recall names LLN since 2007.
Adverse event reports per year · LLN
No MAUDE report names LLN since 2007.
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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010981 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010981: Gsa Genito Sensory Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010981
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026