510(k) · Cleared
ClearedSBV2, Multicharger Model MC10V2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleep Performance D.B.A. Fatigue Science · LEL Device, Sleep Assessment
Cleared on Dec 16, 2011 as substantially equivalent to K040554 (Manufacturing Technology, Inc., 2004) after a 198-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Dec 16, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854030 (1986). 2 later devices descend from it, 2 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 deviceK111514 SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science · 2011
- Descendant · cites it directly · 0 of its ownK233618 Oxevision Sleep DeviceOxehealth Limited · 2024
- Descendant · cites it directly · 0 of its ownK151784 ActTrustCondor Instruments Ltda. - Epp · 2016
Most influential descendants
Showing 2 of 2 · See allView 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) | K111514 | SBV2, Multicharger Model MC10V2 | Sleep Performance D.B.A. Fatigue Science | 2011 | — |
| +1 | K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024 | — |
| +1 | K151784 | ActTrust | Condor Instruments Ltda. - Epp | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256Summary page 1…on Name: GWQ, Electroencephalograph, 882.1400, Class 11 1.3 Identification of Legally Marketed Device SBV2 is substantially equivalent to the ActiGraph device (K040554). 1.4 Device Description The SBV2 System is a device that monitors activity. It relies on the measurement and an… | 2004 |
What descends from it? (2)
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 25 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K233618 (Oxehealth Limited, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040554.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SBV2 System is an activity monitor designed and intended 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 and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111514: SBV2, Multicharger Model MC10V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111514
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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