510(k) · Cleared
ClearedSine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordic Kinetics AB · GYD Transducer, Tremor
Cleared on Jun 17, 2026 as substantially equivalent to K213519 (Rune Labs, Inc., 2022) and 1 other predicate after a 268-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Jun 17, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K854030 (1986). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 7 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 6 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 5 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 4 generations backK080545 ActitrainerActigraph, LLC · 2008
- 3 generations backK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- 2 generations backK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- 1 generation backK220820 Parky AppH2o Bilisim Yazilim · 2022
- This deviceK253055 Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch…Nordic Kinetics AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −7 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −6 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −5 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −4 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −3 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| −2 | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
| −1 | K220820 | Parky App | H2o Bilisim Yazilim | 2022 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K213519 | Rune Labs Tremor Transducer SystemSummary page 5…ducer, Tremor Regulatory Class: Class II Regulation name: 882.1950 Product Code: GYD, NXQ 3. Predicates First legally marketed predicate device Predicate code: K213519 Predicate trade name: Rune Labs Kinematics System Product code: GYD Second legally marketed predicate device Predicate cod… | 2022 |
| * | K220820 | Parky AppSummary page 5…cate device Predicate code: K213519 Predicate trade name: Rune Labs Kinematics System Product code: GYD Second legally marketed predicate device Predicate code: K220820 Predicate trade name: Parky App ("Parky") Product code: GYD, NXQ, ISD Page… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 9 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K213519.
How does its category compare?
All GYD devicesGYD Transducer, Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253055: Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253055
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026