510(k) · Cleared
ClearedRune Labs Tremor Transducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rune Labs, Inc. · GYD Transducer, Tremor
Cleared on Jun 10, 2022 as substantially equivalent to K140086 (Gkc Manufacturing Pty, Ltd., 2014) after a 219-day review. Its family tree reaches back 6 generations to 1986. 4 later devices descend from it.
- Decided
- Jun 10, 2022
- Review
- 219 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K854030 (1986). 15 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 5 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 4 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 3 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 2 generations backK080545 ActitrainerActigraph, LLC · 2008
- 1 generation backK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- This deviceK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK220820 Parky AppH2o Bilisim Yazilim · 2022
- Descendant · 2 generations on · 1 of its ownK250153 Neu PlatformNeuhealth Digital, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK262515 Kneu Platform (V2)Kneu Health Digital, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253055 Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch…Nordic Kinetics AB · 2026
Most influential descendants
Showing 4 of 4 · See all- K220820Parky AppH2o Bilisim Yazilim · 2022 · cites it directly3descendants
- K250153Neu PlatformNeuhealth Digital, Ltd. · 2025 · 2 generations on1descendant
- K262515Kneu Platform (V2)Kneu Health Digital, Ltd. · 2026 · 2 generations on0descendants
- K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −5 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −4 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −3 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −2 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −1 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| 0 (this device) | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
| +1 | K220820 | Parky App | H2o Bilisim Yazilim | 2022 | — |
| +2 | K250153 | Neu Platform | Neuhealth Digital, Ltd. | 2025 | — |
| +2 | K262515 | Kneu Platform (V2) | Kneu Health Digital, Ltd. | 2026 | — |
| +1 | K253055 | Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) | Nordic Kinetics AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K140086 | Personal Kinetigraph (PKG) SystemSummary page 4…stem Common Name: Tremor transducer Classification Name: Transducer, Tremor Regulation Number: 882.1950 Product Code: GYD Legally Marketed Predicate Devices Predicate # K140086 Predicate Trade Name: Personal Kinetigraph (PKG) System Product Code: GYD Device Description Summary The Rune Labs Kinematic Sys… | 2014 |
| † | K161717 | Personal Kinetigraph (PKG) System | 2016 |
| † | DEN180044 | ECG App | 2018 |
| † | DEN180042 | Irregular Rhythm Notification Feature | 2018 |
What descends from it? (4)
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?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K220820 (H2o Bilisim Yazilim, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K140086.
How does its category compare?
All GYD devicesGYD Transducer, Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Rune Labs Kinematic System is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson's disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213519: Rune Labs Tremor Transducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213519
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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