510(k) · Cleared
Recalled · 2007Actiwatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mini-Mitter Co., Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Mar 23, 1999 as substantially equivalent to K854030 (Ambulatory Monitoring, Inc., 1986) after a 166-day review. Its family tree reaches back 1 generation to 1986. 126 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 23, 1999
- Review
- 166 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854030 (1986). 126 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- This deviceK983533 ActiwatchMini-Mitter Co., Inc. · 1999
- Descendant · cites it directly · 73 of its ownK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · cites it directly · 36 of its ownK060919 ActicalRespironics, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · cites it directly · 35 of its ownK991033 Actiwatch-ScoreMini-Mitter Co., Inc. · 1999
Showing 5 of 126 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 126 · See all- K992410ActitracIndividual Monitoring Systems, Inc. · 1999 · cites it directly73descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
- K060919ActicalRespironics, Inc. · 2006 · cites it directly36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 2 generations on35descendants
- K991033Actiwatch-ScoreMini-Mitter Co., Inc. · 1999 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| 0 (this device) | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | — |
| +1 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| +2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +1 | K060919 | Actical | Respironics, Inc. | 2006 | 1 |
| +2 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +1 | K991033 | Actiwatch-Score | Mini-Mitter Co., Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 | 11 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K854030 | Wrist ActigraphSummary page 1…tch® , Common Name: Activity Recording Device Classification Name: System, Telemetry, Physiological Signal Conditioner 10.1.3 Identification of predicate device Number K854030 — Wrist Actigraph — Ambulatory Monitoring, Inc. - Product Code GWQ -24 - Mini-Mitter Co, Inc. 510(k) Premarket N… | 1986 |
| * | — | Mini-Motionlogger Actigraph Named without a submission number |
What descends from it? (126)
See all 1266 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2007 | Not classified | Z-0324-2008 | Software design | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed… |
| Jun 27, 2007 | Not classified | Z-0326-2008 | Software design | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed… |
| Jun 27, 2007 | Not classified | Z-0327-2008 | Software design | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Actiwatch® is an ultra-compact, lightweight, wrist-worn activity and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and score data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable.
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/K983533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983533: Actiwatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983533
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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