510(k) · Cleared
ClearedPersonal Kinetigraph (PKG) System Gen 2 Plus
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 Mar 11, 2022 as substantially equivalent to K161717 (Gkc Manufacturing Pty, Ltd., 2016) after a 263-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- Mar 11, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- GYD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K854030 (1986). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 6 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 5 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 4 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 3 generations backK080545 ActitrainerActigraph, LLC · 2008
- 2 generations backK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- 1 generation backK161717 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016
- This deviceK211887 Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260374 Empatica Health Monitoring Platform for Parkinson's Disease…Empatica S.r.l. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −6 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −5 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −4 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −3 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −2 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| −1 | K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016 | — |
| 0 (this device) | K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022 | — |
| +1 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring… | Empatica S.r.l. | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161717 | Personal Kinetigraph (PKG) SystemSummary page 4…950) Regulatory Class: II Product Codes: GYD, ISD, NXQ 5.3 Predicate Device Personal Kinetigraph (PKG) System Model GKC-2000 (Gen 2) (K161717). The predicate has not been subject to a design-related recall. No reference devices were used in this submission. 5.4… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | 2026 | 0 |
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 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K260374 (Empatica S.r.l., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161717.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211887: Personal Kinetigraph (PKG) System Gen 2 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211887
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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