# K111514: SBV2, Multicharger Model MC10V2

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Performance D.B.A. Fatigue Science
- Decided: Dec 16, 2011 after 198 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854030 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256, Manufacturing Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K233618: Oxevision Sleep Device (2024), 0 descendants of its own
- K151784: ActTrust (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111514
Methodology: https://510kreport.com/methodology