510(k) · Cleared
ClearedActiGraph LEAP activity monitor (ActiGraph LEAP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actigraph, LLC · LEL Device, Sleep Assessment
Cleared on Jun 23, 2023 as substantially equivalent to K181077 (Actigraph, 2018) after a 28-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it.
- Decided
- Jun 23, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K854030 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 5 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 4 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 3 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 2 generations backK080545 ActitrainerActigraph, LLC · 2008
- 1 generation backK181077 ActiGraph CentrePoint Insight WatchActigraph · 2018
- This deviceK231532 ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC · 2023
- Descendant · cites it directly · 0 of its ownK243513 DCM (PW-DCM)Pneumowave, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243513DCM (PW-DCM)Pneumowave, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −5 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −4 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −3 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −2 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −1 | K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018 | — |
| 0 (this device) | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023 | — |
| +1 | K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K181077 | ActiGraph CentrePoint Insight WatchSummary page 4…gally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Product Code Predicate is listed first) K181077 CentrePoint Insight Watch LEL Device Description Summary The ActiGraph LEAP™ is a wrist-worn… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243513 | DCM (PW-DCM) | 2025 | 0 |
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 37 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K243513 (Pneumowave, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181077.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ActiGraph LEAP™ is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and 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/K231532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231532
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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