510(k) · Cleared
ClearedActiSpec Activity Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleep Modus, Inc. · ISD Exerciser, Measuring
Cleared on Aug 26, 2015 as substantially equivalent to K080545 (Actigraph, LLC, 2008) and 1 other predicate after a 258-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Aug 26, 2015
- Review
- 258 days
- Class
- Class II
- Product code
- ISD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854030 (1986). No later device cites it as a predicate yet.
- 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 deviceK143512 ActiSpec Activity MonitorSleep Modus, Inc. · 2015
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) | K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K080545 | ActitrainerSummary page 4…rimary Measuring exercise equipment Classification Name: Product Code: ISD Class 2 890.5360 Predicate Devices: K080545 ActiTrainer ActiGraph, LLC K040554 ActiGraph Manufacturing Technolo… | 2008 |
| * | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256Summary page 4…oduct Code: ISD Class 2 890.5360 Predicate Devices: K080545 ActiTrainer ActiGraph, LLC K040554 ActiGraph Manufacturing Technology, Inc. Device Description: ActiSpec® consists of a pair of toe bands… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 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.
- 4 other devices also cite its predicate K080545.
How does its category compare?
All ISD devicesISD Exerciser, Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ActiSpec® is a small limb worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to 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/K143512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143512: ActiSpec Activity Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143512
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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