510(k) · Cleared
ClearedModification to Bio-Logic Sleepscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Nov 25, 1998 as substantially equivalent to K894155 (Biologic Systems Corp., 1990) after a 21-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 25, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894155 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK894155 SleepscanBiologic Systems Corp. · 1990
- This deviceK983913 Modification to Bio-Logic SleepscanBio-Logic Systems Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894155 | Sleepscan | Biologic Systems Corp. | 1990 | — |
| 0 (this device) | K983913 | Modification to Bio-Logic Sleepscan | Bio-Logic Systems Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K894155 | SleepscanSummary page 1…COMMON NAME: Polysomnography System. CLASSIFICATION NAME: Conditioner, Signal, Physiological (per CFR 882.1845), PREDICATE DEVICE: Bio-logic Sleepscan, reference 510(k) #K894155. DESCRIPTION OF THE DEVICE: The Bio-logic Sleepscan family of products is intended to be used for the recording and analysis of h… | 1990 |
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.
What does this lineage say?
- Its one ancestor has no recall.
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 Bio-logic Sleepscan product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. Sleepscan Analysis performs calculations and presents recorded data in various ways on the computer screen and in reports. The Analysis…
Read the full statement (171 words)
The Bio-logic Sleepscan product family is indicated for use in the recording and analysis of human physiological data
necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can
improve the speed of diagnosis and assist in potential treatment decisions. Sleepscan Analysis performs calculations
and presents recorded data in various ways on the computer screen and in reports. The Analysis features in the
Sleepscan product are intended to be performed without patient hookup being necessary, and may even be performed on
a different computer system from that which was used for the patient recording.
It can be used for patients of all ages, from childrea to adults, including geriatric patients. The use of the Sleepscan
family of products is to be performed under the prescription and supervision of a physician or other trained health care
professional.
The primary feature modification represented in this Special 510(k) is for the use of the Microsoft Windows operating
system and its associated user interface functionality.
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/K983913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983913: Modification to Bio-Logic Sleepscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983913
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026