510(k) · Cleared
ClearedPathway - Ats/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 Jan 19, 2006 as substantially equivalent to K051448 (Medoc Ltd. Advanced Medical Systems, 2005) after a 143-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jan 19, 2006
- Review
- 143 days
- Class
- Class II
- Product code
- NTU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922052 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922052 Tsa 2001 Thermal Sensory AnalyzerMedoc Corp. · 1993
- 2 generations backK041908 Contact Heat-Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- 1 generation backK051448 Modified Contact-Heat Evoked Potential Stimulator (Cheps)Medoc Ltd. Advanced Medical Systems · 2005
- This deviceK052357 Pathway - Ats/ChepsMedoc Ltd. Advanced Medical Systems · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922052 | Tsa 2001 Thermal Sensory Analyzer | Medoc Corp. | 1993 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps)Summary page 4…Name: 21 CFR 882.1870- Trade-name of device: PATHWAY- ATS/CHEPS 3. Predicate Device: Modified Contact Heat-Evoked Potential Stimulator K051448 4. Description: The PATHWAY- ATS/CHEPS is an advanced, computerized thermal stimula… | 2005 |
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 13 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- None of the 4 ancestors has a recall.
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 PATHWAY- ATSICHEPS 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/K052357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052357: Pathway - Ats/Cheps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052357
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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