510(k) · Cleared
ClearedArtisan Acquisition System for Eeg and Polysomnography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsep Corp. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 27, 1999 after a 51-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 114 later devices descend from it.
- Decided
- Aug 27, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
114 later devices descend from it, 1 citing it directly.
- This deviceK992283 Artisan Acquisition System for Eeg and PolysomnographyAirsep Corp. · 1999
- Descendant · cites it directly · 113 of its ownK024322 Embla N7000Medcare Flaga · 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 · 3 generations on · 30 of its ownK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K024322Embla N7000Medcare Flaga · 2003 · cites it directly113descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 2 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 3 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · 2 generations on41descendants
- K061405Apnealink, Model 22302Resmed Germany, Inc. · 2006 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992283 | Artisan Acquisition System for Eeg and Polysomnography | Airsep Corp. | 1999 | — |
| +1 | K024322 | Embla N7000 | Medcare Flaga | 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 | — |
| +3 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (114)
See all 1141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024322 | Embla N7000 | 2003 | 113 |
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, K024322 (Medcare Flaga, 2003) has gone furthest, with 113 descendants of its own.
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 Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.
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/K992283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992283: Artisan Acquisition System for Eeg and Polysomnography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992283
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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