510(k) · Cleared
ClearedTytron C-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titronics Research & Development Co. · HCS Device, Temperature Measurement, Direct Contact, Powered
Cleared on Feb 3, 1998 as substantially equivalent to K950986 (Artronics, 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 3, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- HCS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950986 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950986 NeuroreaderArtronics · 1995
- This deviceK974208 Tytron C-3000Titronics Research & Development Co. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950986 | Neuroreader | Artronics | 1995 | — |
| 0 (this device) | K974208 | Tytron C-3000 | Titronics Research & Development Co. | 1998 | — |
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 HCS? 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 |
|---|---|---|---|
| * | K950986 | NeuroreaderSummary page 1…rological Devices Classification Panel 21 Code of Federal Regulations 882.1570 Class: I Panel: 84 Procode: 84HCS Predicate Device: Thermatrax submitted by Artronics K-950986 Description: The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each con… | 1995 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HCS devicesHCS Device, Temperature Measurement, Direct Contact, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCS
FDA has decided no HCS device since 2007.
Median 510(k) review, days · HCS
Too few HCS 510(k)s in any year since 2007 to give a median.
Recalls per year · HCS
No recall names HCS since 2007.
Adverse event reports per year · HCS
1in 2017
MAUDE reports naming product code HCS, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 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 | 1 |
| 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 TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer.
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/K974208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974208: Tytron C-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974208
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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