510(k) · Cleared
ClearedJtech Commander and Algometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J-Tech Medical, Inc. · HRW Dynamometer, Nonpowered
Cleared on Apr 20, 1998 after a 369-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 20, 1998
- Review
- 369 days
- Class
- Class I
- Product code
- HRW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK971407 Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK011964 Insight Millennium PlusFasstech · 2001
- Descendant · 2 generations on · 4 of its ownK023209 Insight Millennium IiiFasstech · 2003
- Descendant · 3 generations on · 1 of its ownK063447 Insight DiscoveryFasstech · 2007
- Descendant · 4 generations on · 0 of its ownK131094 VimoveDorsa VI Pty., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK123399 Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011964Insight Millennium PlusFasstech · 2001 · cites it directly5descendants
- K023209Insight Millennium IiiFasstech · 2003 · 2 generations on4descendants
- K063447Insight DiscoveryFasstech · 2007 · 3 generations on1descendant
- K131094VimoveDorsa VI Pty., Ltd. · 2014 · 4 generations on0descendants
- K123399Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971407 | Jtech Commander and Algometer | J-Tech Medical, Inc. | 1998 | — |
| +1 | K011964 | Insight Millennium Plus | Fasstech | 2001 | — |
| +2 | K023209 | Insight Millennium Iii | Fasstech | 2003 | — |
| +3 | K063447 | Insight Discovery | Fasstech | 2007 | — |
| +4 | K131094 | Vimove | Dorsa VI Pty., Ltd. | 2014 | — |
| +3 | K123399 | Myovision 3.0 Wirefree System | Precision Biometrics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRW? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011964 | Insight Millennium Plus | 2001 | 5 |
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, K011964 (Fasstech, 2001) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HRW devicesHRW Dynamometer, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRW
FDA has decided no HRW device since 2007.
Median 510(k) review, days · HRW
Too few HRW 510(k)s in any year since 2007 to give a median.
Recalls per year · HRW
No recall names HRW since 2007.
Adverse event reports per year · HRW
1in 2020
MAUDE reports naming product code HRW, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 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 | 1 |
| 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 JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures pressure applied by examiner to ¢licit a response for pain tolcrance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971407: Jtech Commander and Algometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971407
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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