510(k) · Cleared
ClearedH20- Tethered Option
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 Aug 6, 1999 as substantially equivalent to K974587 (Grass-Telefactor Product Group, 1998) after a 30-day review. Its family tree reaches back 3 generations to 1989. 8 later devices descend from it.
- Decided
- Aug 6, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884937 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 2 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 1 generation backK974587 H2OGrass-Telefactor Product Group · 1998
- This deviceK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- Descendant · cites it directly · 6 of its ownK033978 ADAMAstro-Med, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- Descendant · 2 generations on · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · 3 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 4 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K033978ADAMAstro-Med, Inc. · 2004 · cites it directly6descendants
- K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · cites it directly6descendants
- K050425Aura-PSGAstro-Med, Inc. · 2005 · 2 generations on5descendants
- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 3 generations on4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −2 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −1 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| 0 (this device) | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| +1 | K033978 | ADAM | Astro-Med, Inc. | 2004 | — |
| +1 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| +2 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +3 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +4 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
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 |
|---|---|---|---|
| * | K974587 | H2OSummary page 1…V Product class: Class I} Device Tier: 2 This device claims equivalence to: Telefactor Corporation’s “H20” EEG-Recorder for which previously granted 510(k) number is: #K974587 Brief functional description of the device: H20 receives signals from an EEG Amplifier, formats, and transmits them via a cable… | 1998 |
What descends from it? (8)
2 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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033978 (Astro-Med, Inc., 2004) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K974587.
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?
THIS DEVICE 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/K992291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992291: H20- Tethered Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992291
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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