510(k) · Cleared
ClearedActiGraph CentrePoint Insight Watch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actigraph · LEL Device, Sleep Assessment
Cleared on May 24, 2018 as substantially equivalent to K080545 (Actigraph, LLC, 2008) after a 30-day review. Its family tree reaches back 5 generations to 1986. 10 later devices descend from it.
- Decided
- May 24, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K854030 (1986). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 4 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 3 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 2 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 1 generation backK080545 ActitrainerActigraph, LLC · 2008
- This deviceK181077 ActiGraph CentrePoint Insight WatchActigraph · 2018
- Descendant · cites it directly · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · 2 generations on · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- Descendant · 3 generations on · 1 of its ownK252981 EmbraceMiniEmpatica S.r.l. · 2025
- Descendant · 2 generations on · 1 of its ownK232915 EpiMonitorEmpatica S.r.l. · 2024
- Descendant · cites it directly · 1 of its ownK231532 ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · cites it directly7descendants
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · 2 generations on4descendants
- K252981EmbraceMiniEmpatica S.r.l. · 2025 · 3 generations on1descendant
- K232915EpiMonitorEmpatica S.r.l. · 2024 · 2 generations on1descendant
- K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −4 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −3 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −2 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −1 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| 0 (this device) | K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018 | — |
| +1 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +2 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
| +3 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | — |
| +2 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | — |
| +1 | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K080545 | ActitrainerSummary page 4…k Device 21 CFR 882.5050 Product Code: LEL Predicate Device Predicate: ActiTrainer K080545 21 CFR 890.5360, ISD (measuring exercising equipment) Device Description The ActiGraph Centr… | 2008 |
What descends from it? (10)
2 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 32 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K221282 (Empatica S.r.l., 2022) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K080545.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 CentrePoint Insight Watch 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 Insight watch 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/K181077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181077: ActiGraph CentrePoint Insight Watch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181077
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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