510(k) · Cleared
ClearedWrist Actigraph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambulatory Monitoring, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 25, 1986 after a 267-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 129 later devices descend from it.
- Decided
- Jun 25, 1986
- Review
- 267 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
129 later devices descend from it, 3 citing it directly.
- This deviceK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- Descendant · cites it directly · 126 of its ownK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- Descendant · 2 generations on · 73 of its ownK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 36 of its ownK060919 ActicalRespironics, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K983533ActiwatchMini-Mitter Co., Inc. · 1999 · cites it directly126descendants
- K992410ActitracIndividual Monitoring Systems, Inc. · 1999 · 2 generations on73descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
- K060919ActicalRespironics, Inc. · 2006 · 2 generations on36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| +1 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| +2 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| +3 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +2 | K060919 | Actical | Respironics, Inc. | 2006 | 1 |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 14 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (129)
See all 1293 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?
- Of its descendants, K983533 (Mini-Mitter Co., Inc., 1999) has gone furthest, with 126 descendants of its own.
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 | — |
https://510kreport.com/device/K854030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854030: Wrist Actigraph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854030
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026