510(k) · Cleared
ClearedDeeglite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grass-Telefactor Product Group · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Jun 9, 1998 as substantially equivalent to K972202 (Grass-Telefactor Product Group, 1997) after a 203-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 9, 1998
- Review
- 203 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884937 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K972202 | Deeg-LiteSummary page 1…: Class II Device Tier: 2 f. This device claims equivalence to: Telefactor Corporation’s DEEG-LITE Portable EEG- Recorder for which previously granted 510(k) number is: K972202 g. Brief functional description of the device: DEEG-LITE-OXY receives signals from an EEG Amplifier, formats & records them on t… | 1997 |
| † | K962424 | NPB-4000 | 1996 |
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?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K972202.
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 DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).
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/K974583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974583: Deeglite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974583
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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