510(k) · Cleared
ClearedKneu Platform (V2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kneu Health Digital, Ltd. · GYD Transducer, Tremor
Cleared on Aug 20, 2026 as substantially equivalent to K220820 (H2o Bilisim Yazilim, 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Aug 20, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K854030 (1986). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 5 generations between
- 3 generations backK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- 2 generations backK220820 Parky AppH2o Bilisim Yazilim · 2022
- 1 generation backK250153 Neu PlatformNeuhealth Digital, Ltd. · 2025
- This deviceK262515 Kneu Platform (V2)Kneu Health Digital, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 8 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 7 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 6 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 5 generations backK080545 ActitrainerActigraph, LLC · 2008
- 4 generations backK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- 3 generations backK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
- 2 generations backK220820 Parky AppH2o Bilisim Yazilim · 2022
- 1 generation backK250153 Neu PlatformNeuhealth Digital, Ltd. · 2025
- This deviceK262515 Kneu Platform (V2)Kneu Health Digital, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −8 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −7 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −6 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −5 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −4 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| −3 | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
| −2 | K220820 | Parky App | H2o Bilisim Yazilim | 2022 | — |
| −1 | K250153 | Neu Platform | Neuhealth Digital, Ltd. | 2025 | — |
| 0 (this device) | K262515 | Kneu Platform (V2) | Kneu Health Digital, Ltd. | 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 |
|---|---|---|---|
| * | K220820 | Parky AppSummary page 5…Use in this submission Product Code Number H2O Therapeutics Parky App 21 CFR 882.1950; K220820 Predicate for Apple Watch passive GYD, NXQ, ISD tremor and dys… | 2022 |
| * | K250153 | Neu PlatformSummary page 5…pportive NXQ/ISD functions. Neuhealth Digital Neu Platform 21 CFR 882.1950; K250153 Predicate for unchanged active Ltd. / Kneu Health / Kneu GYD smartphone-based… | 2025 |
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 10 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 2 other devices also cite its predicate K220820.
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?
The Kneu Platform is intended to quantify the kinematics of movement disorder symptoms, including tremor and dyskinesia, in adults (45 years and older) with mild to moderate Parkinson’s disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262515: Kneu Platform (V2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262515
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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