510(k) · Cleared
ClearedTremorometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexable Systems, Inc. · GYD Transducer, Tremor
Cleared on Jul 25, 2001 after a 177-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jul 25, 2001
- Review
- 177 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK010270 TremorometerFlexable Systems, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK063872 KinesiaCleveland Medical Devices, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- Descendant · 3 generations on · 4 of its ownK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK220820 Parky AppH2o Bilisim Yazilim · 2022
- Descendant · 3 generations on · 3 of its ownK161717 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K063872KinesiaCleveland Medical Devices, Inc. · 2007 · cites it directly10descendants
- K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · 2 generations on9descendants
- K213519Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022 · 3 generations on4descendants
- K220820Parky AppH2o Bilisim Yazilim · 2022 · 4 generations on3descendants
- K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010270 | Tremorometer | Flexable Systems, Inc. | 2001 | — |
| +1 | K063872 | Kinesia | Cleveland Medical Devices, Inc. | 2007 | — |
| +2 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| +3 | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
| +4 | K220820 | Parky App | H2o Bilisim Yazilim | 2022 | — |
| +3 | K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Axiom Named without a submission number | |
| * | — | FlexiPlus™ Named without a submission number | |
| * | — | Actiwatch® Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063872 | Kinesia | 2007 | 10 |
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, K063872 (Cleveland Medical Devices, Inc., 2007) has gone furthest, with 10 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 Tremorometer is designed to be used to measure and record tri-axial readings of a patient’s tremor motions, to optionally combine the three axis tremor information into a single measurement of total tremor movement by a proprietary algorithm that eliminates some of the rotational, orientation and other artifacts, to display the information graphically, and to transfer the data to a PC for further analysis, display, printing or storage.
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/K010270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010270: Tremorometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010270
Report an extraction error
Are you the manufacturer?
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