510(k) · Cleared
ClearedInsight Millennium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fasstech · HCC Device, Biofeedback
Cleared on Jun 3, 1999 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jun 3, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK990778 Insight MillenniumFasstech · 1999
- 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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) | K990778 | Insight Millennium | Fasstech | 1999 | — |
| +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 | 2 | 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 HCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (7)
2 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?
- Of its descendants, K011964 (Fasstech, 2001) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 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 chart patient progress during the course of treatment
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/K990778 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990778: Insight Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990778
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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