510(k) · Cleared
ClearedContact Heat-Evoked Potential Stimulator (Cheps)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medoc Ltd. Advanced Medical Systems · NTU Evoked Potential Stimulator, Thermal
Cleared on Feb 25, 2005 as substantially equivalent to K010981 (Medoc Ltd. Advanced Medical Systems, 2001) and 1 other predicate after a 225-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 225 days
- Class
- Class II
- Product code
- NTU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922052 (1993). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922052 Tsa 2001 Thermal Sensory AnalyzerMedoc Corp. · 1993
- This deviceK041908 Contact Heat-Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- Descendant · cites it directly · 1 of its ownK051448 Modified Contact-Heat Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- Descendant · 2 generations on · 0 of its ownK052357 Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922052 | Tsa 2001 Thermal Sensory Analyzer | Medoc Corp. | 1993 | — |
| 0 (this device) | K041908 | Contact Heat-Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| +1 | K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| +2 | K052357 | Pathway - Ats/Cheps | Medoc Ltd. Advanced Medical Systems | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 NTU? 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? (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 |
|---|---|---|---|
| * | K010981 | Gsa Genito Sensory AnalyzerSummary page 1…GSA Genito · TSA-2001 Sensory Analyzer Thermal (K010981), Sensory manufactured by Analyzer… | 2001 |
| * | K922052 | Tsa 2001 Thermal Sensory AnalyzerSummary page 1…Sensory manufactured by Analyzer Medoc Ltd. (K922052), Advanced Medical manufactur Systems.… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps) | 2005 | 1 |
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.
- Of its descendants, K051448 (Medoc Ltd. Advanced Medical Systems, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NTU devicesNTU Evoked Potential Stimulator, Thermal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTU
FDA has decided no NTU device since 2007.
Median 510(k) review, days · NTU
Too few NTU 510(k)s in any year since 2007 to give a median.
Recalls per year · NTU
No recall names NTU since 2007.
Adverse event reports per year · NTU
1in 2008
MAUDE reports naming product code NTU, 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 | 1 |
| 2009 | 0 | — | 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 | — |
What is it indicated for?
The Contact Heat-Evoked Potential Stimulator (CHEPS) is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041908 · printed Nov 3, 2026
Cite this page
510(k) Report. “K041908: Contact Heat-Evoked Potential Stimulator (Cheps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041908
Report an extraction error
Are you the manufacturer?
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