510(k) · Cleared
ClearedKinesia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Medical Devices, Inc. · GYD Transducer, Tremor
Cleared on Apr 6, 2007 as substantially equivalent to K042039 (Cleveland Medical Devices, Inc., 2004) and 2 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1986. 10 later devices descend from it.
- Decided
- Apr 6, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K854030 (1986). 8 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 2 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 1 generation backK991033 Actiwatch-ScoreMini-Mitter Co., Inc. · 1999
- This deviceK063872 KinesiaCleveland Medical Devices, Inc. · 2007
- 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 |
|---|---|---|---|---|---|
| −3 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −2 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −1 | K991033 | Actiwatch-Score | Mini-Mitter Co., Inc. | 1999 | — |
| 0 (this device) | K063872 | Kinesia | Cleveland Medical Devices, Inc. | 2007 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
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 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 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? (3)
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 |
|---|---|---|---|
| * | K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120Summary page 1…land, Ohio 44103 (216) 791-6720 (216) 791-6739 Date April §, 2007 Name Hani Kayyali, President Classification 882.1400 Predicate: Family of Crystal 20 Monitors, K042039, Tremorometer, K010270, and Actiwatch-Score, K991033. Description: Kinesia™ is designed to monitor of muscle to quantify kinema… | 2004 |
| * | K010270 | TremorometerSummary page 1…791-6720 (216) 791-6739 Date April §, 2007 Name Hani Kayyali, President Classification 882.1400 Predicate: Family of Crystal 20 Monitors, K042039, Tremorometer, K010270, and Actiwatch-Score, K991033. Description: Kinesia™ is designed to monitor of muscle to quantify kinematics of] research and d… | 2001 |
| * | K991033 | Actiwatch-ScoreSummary page 1…April §, 2007 Name Hani Kayyali, President Classification 882.1400 Predicate: Family of Crystal 20 Monitors, K042039, Tremorometer, K010270, and Actiwatch-Score, K991033. Description: Kinesia™ is designed to monitor of muscle to quantify kinematics of] research and diagnostic purposes. d record… | 1999 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140086 (Gkc Manufacturing Pty, Ltd., 2014) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K042039.
How does its category compare?
All GYD devicesGYD Transducer, Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Kinesia is intended to monitor physical motions and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.
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/K063872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063872: Kinesia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063872
Report an extraction error
Are you the manufacturer?
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