510(k) · Cleared
ClearedMotion Watch and Pro-Diary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camntech, Ltd. · LEL Device, Sleep Assessment
Cleared on Jan 21, 2014 as substantially equivalent to K983533 (Mini-Mitter Co., Inc., 1999) and 1 other predicate after a 139-day review. Its family tree reaches back 3 generations to 1986. 10 later devices descend from it.
- Decided
- Jan 21, 2014
- Review
- 139 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854030 (1986). 10 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 2 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 1 generation backK991033 Actiwatch-ScoreMini-Mitter Co., Inc. · 1999
- This deviceK132764 Motion Watch and Pro-DiaryCamntech, Ltd. · 2014
- Descendant · cites it directly · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · cites it directly6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 2 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 3 generations on3descendants
- K212160SimpleSENSE PlatformNanowear, Inc. · 2021 · 4 generations on1descendant
- K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025 · 4 generations on0descendants
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 | K991033 | Actiwatch-Score | Mini-Mitter Co., Inc. | 1999 | — |
| 0 (this device) | K132764 | Motion Watch and Pro-Diary | Camntech, Ltd. | 2014 | — |
| +1 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +2 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +3 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +4 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +4 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 LEL? 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 LEL device
- #1 K252981 EmbraceMiniscore 23.3 · 40 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…Product Code: LEL 5.1.3, Identification ofpredicate devices Actiwvatch® (Mini-Mitter Co. Inc.), 510(k) Number : K983533 Actiwatch-Score®(Mini-Mitter Co. Inc.), 5 10(k) Number: K991033 5.2 Device description 5.2.1… | 1999 |
| * | K991033 | Actiwatch-ScoreSummary page 1…ntification ofpredicate devices Actiwvatch® (Mini-Mitter Co. Inc.), 510(k) Number : K983533 Actiwatch-Score®(Mini-Mitter Co. Inc.), 5 10(k) Number: K991033 5.2 Device description 5.2.1.1 Functions of the device Mo/ion Watch and PRO-D… | 1999 |
What descends from it? (10)
4 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 28 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142476 (Healthwatch, Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K983533.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LEL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
MAUDE reports naming product code LEL, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a…
Read the full statement (105 words)
The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired.
Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132764: Motion Watch and Pro-Diary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132764
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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