510(k) · Cleared
ClearedActitrainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actigraph, LLC · ISD Exerciser, Measuring
Cleared on Jul 24, 2008 as substantially equivalent to K040554 (Manufacturing Technology, Inc., 2004) after a 148-day review. Its family tree reaches back 4 generations to 1986. 23 later devices descend from it.
- Decided
- Jul 24, 2008
- Review
- 148 days
- Class
- Class II
- Product code
- ISD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854030 (1986). 23 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 3 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 2 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 1 generation backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- This deviceK080545 ActitrainerActigraph, LLC · 2008
- Descendant · cites it directly · 10 of its ownK181077 ActiGraph CentrePoint Insight WatchActigraph · 2018
- Descendant · cites it directly · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
- Descendant · 2 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · 3 generations on · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- Descendant · 2 generations on · 4 of its ownK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K181077ActiGraph CentrePoint Insight WatchActigraph · 2018 · cites it directly10descendants
- K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · cites it directly9descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 2 generations on7descendants
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · 3 generations on4descendants
- K213519Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −3 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −2 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −1 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| 0 (this device) | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| +1 | K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018 | — |
| +1 | K140086 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2014 | — |
| +2 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +3 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
| +2 | K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 ISD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256Summary page 1…sification Name: ISD Equivalent Legally Marketed device: The ActiTrainer is similar in function to the ActiGraph LLC's legally marketed activity monitor, the Actigraph, K040554. Description of Device: The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm… | 2004 |
What descends from it? (23)
See all 235 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 22 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K181077 (Actigraph, 2018) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K040554.
How does its category compare?
All ISD devicesISD Exerciser, Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ISD
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · ISD
Too few ISD 510(k)s in any year since 2007 to give a median.
Recalls per year · ISD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISD
2in 2025
MAUDE reports naming product code ISD, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ActiTrainer 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 ActiTrainer 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/K080545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080545: Actitrainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080545
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