510(k) · Cleared
ClearedSomno Star & Series Sleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 2, 2001 as substantially equivalent to K915856 (Sensor Medics Corp., 1992) after a 30-day review. Its family tree reaches back 1 generation to 1992. 99 later devices descend from it.
- Decided
- Aug 2, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915856 (1992). 99 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915856 Sensormedics 4000 Series Sleep SystemSensor Medics Corp. · 1992
- This deviceK012085 Somno Star & Series Sleep SystemSensor Medics Corp. · 2001
- Descendant · cites it directly · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 2 generations on · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 3 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
- Descendant · 2 generations on · 31 of its ownK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · cites it directly98descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 2 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 3 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · 2 generations on41descendants
- K040576Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915856 | Sensormedics 4000 Series Sleep System | Sensor Medics Corp. | 1992 | — |
| 0 (this device) | K012085 | Somno Star & Series Sleep System | Sensor Medics Corp. | 2001 | — |
| +1 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +2 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +3 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +2 | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
| +2 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 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 |
|---|---|---|---|
| * | K915856 | Sensormedics 4000 Series Sleep SystemSummary page 1…d Non-Clinical Tests of Equivalsncy: The SensorMedics SomnoStar O Series Sleep System is equivalent to the SensorMadios 4000 Series Sleep System distributed under 510(k) K915856. The primary difference is the inclusion of a different, optional bio-physical amplifier, the Caphalo Pro, to:replace either the… | 1992 |
What descends from it? (99)
See all 991 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030379 | Aplab, Model 801D0030 | 2003 | 98 |
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?
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (137 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012085: Somno Star & Series Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012085
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026