510(k) · Cleared
ClearedMM-1 Movement Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Instruments, Inc. · GYD Transducer, Tremor
Cleared on Jul 28, 1997 after a 110-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Jul 28, 1997
- Review
- 110 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK971318 MM-1 Movement MonitorAxon Instruments, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- Descendant · 2 generations on · 4 of its ownK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK220820 Parky AppH2o Bilisim Yazilim · 2022
- Descendant · 2 generations on · 3 of its ownK161717 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016
- Descendant · 4 generations on · 1 of its ownK250153 Neu PlatformNeuhealth Digital, Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · cites it directly9descendants
- K213519Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022 · 2 generations on4descendants
- K220820Parky AppH2o Bilisim Yazilim · 2022 · 3 generations on3descendants
- K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016 · 2 generations on3descendants
- K250153Neu PlatformNeuhealth Digital, Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971318 | MM-1 Movement Monitor | Axon Instruments, Inc. | 1997 | — |
| +1 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| +2 | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
| +3 | K220820 | Parky App | H2o Bilisim Yazilim | 2022 | — |
| +2 | K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016 | — |
| +4 | K250153 | Neu Platform | Neuhealth Digital, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 GYD? 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 GYD device
- #1 K260374 Empatica Health Monitoring Platform for…score 21.5 · 41 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140086 | Personal Kinetigraph (PKG) System | 2014 | 9 |
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, K140086 (Gkc Manufacturing Pty, Ltd., 2014) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GYD devicesGYD Transducer, Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GYD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYD
241in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GYD
No recall names GYD since 2007.
Adverse event reports per year · GYD
3in 2023
MAUDE reports naming product code GYD, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 241 | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 190 | 0 | — |
What is it indicated for?
The MM-1 provides useful, quantitative measurements of several neurclogically relevant movciment phenomena: tremor, dexterity and reaction/movemerit time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.
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/K971318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971318: MM-1 Movement Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971318
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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