510(k) · Cleared
ClearedSleep Study Analysis (Ssa) Version 96.10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Results · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Apr 2, 1997 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 2, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
This product is indicated for use under the supervision of a Physician. This product is indicated for use in the computer aided scoring of sleep study recordings. PATIENT POPULATION SSA is intended for use in the adult population with suspected disorders of sleep. PHYSIOLOGICAL PARAMETERS SSA is intended for use in providing computer assisted human review of the following physiological parameters for the purpose of staging and identifying events in…
Read the full statement (184 words)
This product is indicated for use under the supervision of a Physician.
This product is indicated for use in the computer aided scoring of sleep study recordings.
PATIENT POPULATION
SSA is intended for use in the adult population with suspected disorders of sleep.
PHYSIOLOGICAL PARAMETERS
SSA is intended for use in providing computer assisted human review of the following physiological parameters for the purpose of staging and identifying events in sleep:
Electroencephalogram
Electromyogram
Electrocardiogram
Respiratory Effort
Respiratory Air Flow
Pulse Oximetry
CLINICAL UTILITY OF SUMMARY REPORT OUTPUT
The clinical utility of SSA summary report output is to assist a trained clinician in the review of polysomnographic recordings so that the clinician may more easily identify sleep stage events. SSA is indicated for use only when operated by a trained clinician who reviews and determines the presence of sleep stage events. SSA is in no way intended to replace a human clinician in discriminating the existence and type of any sleep event which may have occurred.
ENVIRONMENT OF USE:
SSA is indicated for use in a hospital sleep laboratory or a free standing sleep laboratory.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963631: Sleep Study Analysis (Ssa) Version 96.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963631
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026