510(k) · Cleared
ClearedInsight Millennium Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fasstech · IKN Electromyograph, Diagnostic
Cleared on Oct 10, 2003 as substantially equivalent to K011964 (Fasstech, 2001) and 1 other predicate after a 379-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 379 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971407 (1998). 4 ancestors in all, the oldest K914925 (1993). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971407 Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
- 1 generation backK011964 Insight Millennium PlusFasstech · 2001
- This deviceK023209 Insight Millennium IiiFasstech · 2003
- Descendant · cites it directly · 1 of its ownK063447 Insight DiscoveryFasstech · 2007
- Descendant · 2 generations on · 0 of its ownK131094 VimoveDorsa VI Pty., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK123399 Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK033452 CWAS 1000Fasstech · 2003
Most influential descendants
Showing 4 of 4 · See all- K063447Insight DiscoveryFasstech · 2007 · cites it directly1descendant
- K131094VimoveDorsa VI Pty., Ltd. · 2014 · 2 generations on0descendants
- K123399Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013 · cites it directly0descendants
- K033452CWAS 1000Fasstech · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971407 | Jtech Commander and Algometer | J-Tech Medical, Inc. | 1998 | — |
| −1 | K011964 | Insight Millennium Plus | Fasstech | 2001 | — |
| 0 (this device) | K023209 | Insight Millennium Iii | Fasstech | 2003 | — |
| +1 | K063447 | Insight Discovery | Fasstech | 2007 | — |
| +2 | K131094 | Vimove | Dorsa VI Pty., Ltd. | 2014 | — |
| +1 | K123399 | Myovision 3.0 Wirefree System | Precision Biometrics, Inc. | 2013 | — |
| +1 | K033452 | CWAS 1000 | Fasstech | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 IKN? 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 |
|---|---|---|---|
| * | K011964 | Insight Millennium Plus | 2001 |
| * | K914925 | Medac System/3Summary page 3…Number Insight Millennium Plus Fasstech KO 1 1964 Medac Systed3 Davicon K9 14925 The Insight Millennium I11 is equivalent to these legally marketed devices in the following ways: ’ The physical characteris… | 1993 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063447 (Fasstech, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To measure bilateral differences in skin temperature along the spine
To measure ange of Motion of the three spinal regions
To measure atient self-reported pressure sensitivity in joints and muscles .
To measure Heart Rate
To chart patient progress during the course of treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023209: Insight Millennium Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023209
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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