510(k) · Cleared
ClearedNeuroRPM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Touch Digital, Inc. · GYD Transducer, Tremor
Cleared on Mar 17, 2023 as substantially equivalent to K161717 (Gkc Manufacturing Pty, Ltd., 2016) after a 269-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Mar 17, 2023
- Review
- 269 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. No later device cites it as a predicate yet.
- 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 deviceK221772 NeuroRPMNew Touch Digital, Inc. · 2023
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) | 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 |
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…Predicate Device: Manufacturer: GKC Manufacturing Pty Ltd. Trade/Device Name: Personal Kinetigraph (PKG) System Model GKC-2000 510(K) Number: K161717 Decision Date: September 20, 2016 Device Description: NeuroRPM is a software application for the Apple Watch t… | 2016 |
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 37 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 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. 2023, 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?
NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. NeuroRPM is intended for clinic and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221772 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221772: NeuroRPM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221772
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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