510(k) · Cleared
ClearedModified Contact-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 Jun 29, 2005 as substantially equivalent to K041908 (Medoc Ltd. Advanced Medical Systems, 2005) after a 27-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jun 29, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- NTU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922052 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922052 Tsa 2001 Thermal Sensory AnalyzerMedoc Corp. · 1993
- 1 generation backK041908 Contact Heat-Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- This deviceK051448 Modified Contact-Heat Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- Descendant · cites it directly · 0 of its ownK052357 Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006
Most influential descendants
Showing 1 of 1 · See all- K052357Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922052 | Tsa 2001 Thermal Sensory Analyzer | Medoc Corp. | 1993 | — |
| −1 | K041908 | Contact Heat-Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| 0 (this device) | K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | 2005 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K041908 | Contact Heat-Evoked Potential Stimulator (Cheps)Summary page 1…82.1870- Modified Contact Heat-Evoked Potential Stimulator (CHEPS) 3. Predicate Device: Contact Heat-Evoked Potential Stimulator K041908 4. Description: The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is an… | 2005 |
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 |
|---|---|---|---|
| K052357 | Pathway - Ats/Cheps | 2006 | 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 12 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052357 (Medoc Ltd. Advanced Medical Systems, 2006) has gone furthest, with 0 descendants 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 Modified Contact Heat-Evoked Potential (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/K051448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051448: Modified Contact-Heat Evoked Potential Stimulator (Cheps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051448
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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