# K012085: Somno Star & Series Sleep System

- Pathway: 510(k) (Special)
- Applicant: Sensor Medics Corp.
- Decided: Aug 2, 2001 after 30 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915856 (1992). 1 ancestor in all.
99 later devices descend from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915856: Sensormedics 4000 Series Sleep System, Sensor Medics Corp. (1992) Summary page 1.

## Most influential descendants
- K030379: Aplab, Model 801D0030 (2003), 98 descendants of its own
- K041904: Compass F10 System (2004), 54 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K041724: Compass M10 System (2004), 41 descendants of its own
- K040576: Micromesam Basic-Set (2004), 31 descendants of its own

## Indications for use
The SomnoStar a Serigs Sleep System is indicated for use to assist the user(s) In diagnosing patients with sleep disorders; by colladting physiological data from a slesping:patlent, assisting the user(s) in performing analysis of sleep data and printing a hard copy of these data. The data is collected, staged and scored with a computer-assisted program. In use, the SomnoStara Series Sleep System reiceives input from optional biophysical amplifiers, up to-32 channels Iin each, which is converted from analog to digital data and stored in a computer storage medium. The SomnoStar a Seriea Sleep System is not intended to be used alone or in combination with another prodg!qct as a life support device, a life support system, or as a criticall cdmponent to a life support device or system. We do not claim compatibility with diagnostic imaging equipment.

Source page: https://510kreport.com/device/K012085
Methodology: https://510kreport.com/methodology