510(k) · Cleared
ClearedActigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manufacturing Technology, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jul 16, 2004 as substantially equivalent to K983533 (Mini-Mitter Co., Inc., 1999) and 1 other predicate after a 136-day review. Its family tree reaches back 3 generations to 1986. 27 later devices descend from it.
- Decided
- Jul 16, 2004
- Review
- 136 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854030 (1986). 27 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 2 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 1 generation backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- This deviceK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- Descendant · cites it directly · 23 of its ownK080545 ActitrainerActigraph, LLC · 2008
- Descendant · 2 generations on · 10 of its ownK181077 ActiGraph CentrePoint Insight WatchActigraph · 2018
- Descendant · 2 generations on · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · 4 generations on · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K080545ActitrainerActigraph, LLC · 2008 · cites it directly23descendants
- K181077ActiGraph CentrePoint Insight WatchActigraph · 2018 · 2 generations on10descendants
- K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · 2 generations on9descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 3 generations on7descendants
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −2 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −1 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| 0 (this device) | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| +1 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| +2 | K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018 | — |
| +2 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| +3 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +4 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 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 |
|---|---|---|---|
| * | K983533 | ActiwatchSummary page 1…vice Classification Name: Electroencephalograph (as per 21 CFR 882.1400) 8.4 Identification of Predicate Devices Number K983533 - "Actiwatch" - Mini-Mitter Number K992410 - "Actitrac" - Individual Monitoring, Inc. Produ… | 1999 |
| * | K992410 | ActitracSummary page 1…graph (as per 21 CFR 882.1400) 8.4 Identification of Predicate Devices Number K983533 - "Actiwatch" - Mini-Mitter Number K992410 - "Actitrac" - Individual Monitoring, Inc. Product Code - GWQ 8.5 Statement of Intended Use… | 1999 |
What descends from it? (27)
See all 273 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 18 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K080545 (Actigraph, LLC, 2008) has gone furthest, with 23 descendants of its own.
- 5 other devices also cite its predicate K983533.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Actigraph is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The Actigraph can be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040554
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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