510(k) · Cleared
ClearedSensormedics 4000 Series Sleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Oct 26, 1992 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 245 later devices descend from it.
- Decided
- Oct 26, 1992
- Review
- 304 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 0
245 later devices descend from it, 5 citing it directly.
- This deviceK915856 Sensormedics 4000 Series Sleep SystemSensor Medics Corp. · 1992
- Descendant · cites it directly · 99 of its ownK012085 Somno Star & Series Sleep SystemSensor Medics Corp. · 2001
- Descendant · 2 generations on · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · cites it directly · 96 of its ownK981034 Silent Night IISleep Solutions, Inc. · 1998
- Descendant · cites it directly · 69 of its ownK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · 2 generations on · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 245 · See all- K012085Somno Star & Series Sleep SystemSensor Medics Corp. · 2001 · cites it directly99descendants
- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · 2 generations on98descendants
- K981034Silent Night IISleep Solutions, Inc. · 1998 · cites it directly96descendants
- K000253Silent Night VSleep Solutions, Inc. · 2000 · cites it directly69descendants
- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · 2 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915856 | Sensormedics 4000 Series Sleep System | Sensor Medics Corp. | 1992 | — |
| +1 | K012085 | Somno Star & Series Sleep System | Sensor Medics Corp. | 2001 | — |
| +2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +1 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| +1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +2 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 8 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 23 | 0 |
| 2023 | 12 | 0 |
| 2024 | 17 | 0 |
| 2025 | 27 | 0 |
| 2026 | 25 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (245)
See all 2455 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?
- Of its descendants, K012085 (Sensor Medics Corp., 2001) has gone furthest, with 99 descendants of its own.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
https://510kreport.com/device/K915856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915856: Sensormedics 4000 Series Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915856
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026