510(k) · Cleared
ClearedInsight Millennium Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fasstech · HCC Device, Biofeedback
Cleared on Sep 20, 2001 as substantially equivalent to K990778 (Fasstech, 1999) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Sep 20, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971407 (1998). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971407 Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
- This deviceK011964 Insight Millennium PlusFasstech · 2001
- Descendant · cites it directly · 4 of its ownK023209 Insight Millennium IiiFasstech · 2003
- Descendant · 2 generations on · 1 of its ownK063447 Insight DiscoveryFasstech · 2007
- Descendant · 3 generations on · 0 of its ownK131094 VimoveDorsa VI Pty., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK123399 Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK033452 CWAS 1000Fasstech · 2003
Most influential descendants
Showing 5 of 5 · See all- K023209Insight Millennium IiiFasstech · 2003 · cites it directly4descendants
- K063447Insight DiscoveryFasstech · 2007 · 2 generations on1descendant
- K131094VimoveDorsa VI Pty., Ltd. · 2014 · 3 generations on0descendants
- K123399Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013 · 2 generations on0descendants
- K033452CWAS 1000Fasstech · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971407 | Jtech Commander and Algometer | J-Tech Medical, Inc. | 1998 | — |
| 0 (this device) | K011964 | Insight Millennium Plus | Fasstech | 2001 | — |
| +1 | K023209 | Insight Millennium Iii | Fasstech | 2003 | — |
| +2 | K063447 | Insight Discovery | Fasstech | 2007 | — |
| +3 | K131094 | Vimove | Dorsa VI Pty., Ltd. | 2014 | — |
| +2 | K123399 | Myovision 3.0 Wirefree System | Precision Biometrics, Inc. | 2013 | — |
| +2 | K033452 | CWAS 1000 | Fasstech | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K990778 | Insight MillenniumSummary page 3…ess. The Algometer utilized in the Insight Millennium Plus is substantially equivalent to the JTECH Commander™ Algometer (510(k): K971407): Fasstech Insight Millennium (K990778) JTECH Commander™ Algometer (K971407) Feature Insight Insight Commander Millennium Plus Millennium Algometer Four Channels of… | 1999 |
| * | K971407 | Jtech Commander and AlgometerSummary page 3…ain threshold, and trigger point tenderness. The Algometer utilized in the Insight Millennium Plus is substantially equivalent to the JTECH Commander™ Algometer (510(k): K971407): Fasstech Insight Millennium (K990778) JTECH Commander™ Algometer (K971407) Feature Insight Insight Commander Millennium Plus… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023209 | Insight Millennium Iii | 2003 | 4 |
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?
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 measure patient self-reported pressure sensitivity in joints and muscles
To chart patient progress during the course of treatment
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/K011964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011964: Insight Millennium Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011964
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026