510(k) · Cleared
ClearedPersonal Kinetigraph (PKG) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gkc Manufacturing Pty, Ltd. · GYD Transducer, Tremor
Cleared on Sep 20, 2016 as substantially equivalent to K140086 (Gkc Manufacturing Pty, Ltd., 2014) after a 90-day review. Its family tree reaches back 6 generations to 1986. 3 later devices descend from it.
- Decided
- Sep 20, 2016
- Review
- 90 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. 3 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 deviceK161717 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK211887 Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260374 Empatica Health Monitoring Platform for Parkinson's Disease…Empatica S.r.l. · 2026
- Descendant · cites it directly · 0 of its ownK221772 NeuroRPMNew Touch Digital, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd. · 2022 · cites it directly1descendant
- K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l. · 2026 · 2 generations on0descendants
- K221772NeuroRPMNew Touch Digital, Inc. · 2023 · 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) | K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016 | — |
| +1 | K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022 | — |
| +2 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring… | Empatica S.r.l. | 2026 | — |
| +1 | K221772 | NeuroRPM | New Touch Digital, Inc. | 2023 | — |
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 |
| 2023 | 1 | 0 |
| 2026 | 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? (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…r (21 CFR 882.1950) Regulatory Class: II Primary Product Code: GYD, ISD, NXQ 5.3 PREDICATE DEVICE K140086 - Global Kinetics Corporation’s Personal Kinetigraph (PKG) System, the previous version of the same system that… | 2014 |
What descends from it? (3)
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 30 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K211887 (Gkc Manufacturing Pty, Ltd., 2022) has gone furthest, with 1 descendant 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. 2016, 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 Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161717: Personal Kinetigraph (PKG) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161717
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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