510(k) · Cleared
ClearedActiwatch-Score
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 Jun 23, 1999 as substantially equivalent to K983533 (Mini-Mitter Co., Inc., 1999) after an 86-day review. Its family tree reaches back 2 generations to 1986. 35 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854030 (1986). 35 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 1 generation backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- This deviceK991033 Actiwatch-ScoreMini-Mitter Co., Inc. · 1999
- Descendant · cites it directly · 12 of its ownK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK132764 Motion Watch and Pro-DiaryCamntech, Ltd. · 2014
- Descendant · cites it directly · 10 of its ownK063872 KinesiaCleveland Medical Devices, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- Descendant · 2 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K093976Raisin Personal MonitorProteus Biomedical, Inc. · 2010 · cites it directly12descendants
- K132764Motion Watch and Pro-DiaryCamntech, Ltd. · 2014 · cites it directly10descendants
- K063872KinesiaCleveland Medical Devices, Inc. · 2007 · cites it directly10descendants
- K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · 2 generations on9descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −1 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| 0 (this device) | K991033 | Actiwatch-Score | Mini-Mitter Co., Inc. | 1999 | — |
| +1 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| +1 | K132764 | Motion Watch and Pro-Diary | Camntech, Ltd. | 2014 | — |
| +1 | K063872 | Kinesia | Cleveland Medical Devices, Inc. | 2007 | — |
| +2 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| +2 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K983533 | ActiwatchSummary page 1…Score® Common Name: Activity Recording Device Classification Name: System, Telemetry, Physiological Signal Conditioner 10.1.3 Identification of predicate device Number K983533 — Wrist Actigraph — Mini Mitter Co., Inc. - Product Code GYE - 26 - Mini-Mitter Co, Inc. 510(k) Premarket Notifi… | 1999 |
What descends from it? (35)
See all 353 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 13 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K093976 (Proteus Biomedical, Inc., 2010) has gone furthest, with 12 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 Actiwatch-Score® is a compact, lightweight, wrist-worn activity monitor that can be used to analyze circadian rhythms, automatically collect and analyze data for sleep parametefs, and assess activity in any instance where quantifiable analysis of physical motion is desirable. In addition, the Actiwatch-Score® has a built-in score pad that allows the subject to subjectively assign and enter a score from 0 to 9. The score pad can be used as a substitute or in addition to the traditional patient diary used in conjunction with activity monitoring.
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/K991033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991033: Actiwatch-Score.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991033
Report an extraction error
Are you the manufacturer?
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