510(k) · Cleared
ClearedInsight Discovery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fasstech · IKN Electromyograph, Diagnostic
Cleared on Aug 16, 2007 as substantially equivalent to K023209 (Fasstech, 2003) after a 274-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Aug 16, 2007
- Review
- 274 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971407 (1998). 5 ancestors in all, the oldest K914925 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK971407 Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
- 2 generations backK011964 Insight Millennium PlusFasstech · 2001
- 1 generation backK023209 Insight Millennium IiiFasstech · 2003
- This deviceK063447 Insight DiscoveryFasstech · 2007
- Descendant · cites it directly · 0 of its ownK131094 VimoveDorsa VI Pty., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K131094VimoveDorsa VI Pty., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971407 | Jtech Commander and Algometer | J-Tech Medical, Inc. | 1998 | — |
| −2 | K011964 | Insight Millennium Plus | Fasstech | 2001 | — |
| −1 | K023209 | Insight Millennium Iii | Fasstech | 2003 | — |
| 0 (this device) | K063447 | Insight Discovery | Fasstech | 2007 | — |
| +1 | K131094 | Vimove | Dorsa VI Pty., Ltd. | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023209 | Insight Millennium IiiSummary page 3…: Manufacturer Predicate Device Name 5 10(k) Number Insight Millennium Ill Fasstech K023209 The Insight Discovery is equivalent to this legally marketed device in the following ways: The physical characteristics and… | 2003 |
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 |
|---|---|---|---|
| K131094 | Vimove | 2014 | 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 9 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131094 (Dorsa VI Pty., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023209.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Range of Motion of the three spinal regions
To measure patient 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/K063447 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063447: Insight Discovery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063447
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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