510(k) · Cleared
ClearedComet-PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Nov 3, 2017 as substantially equivalent to K021807 (Grass Instrument Co., 2002) after a 56-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Nov 3, 2017
- Review
- 56 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000068 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 1 generation backK021807 Grass-Telefactor AS40 Amplifier SystemGrass Instrument Co. · 2002
- This deviceK172711 Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2017
- Descendant · cites it directly · 1 of its ownK180290 Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −1 | K021807 | Grass-Telefactor AS40 Amplifier System | Grass Instrument Co. | 2002 | — |
| 0 (this device) | K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017 | — |
| +1 | K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | 1 |
| +2 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K021807 | Grass-Telefactor AS40 Amplifier SystemSummary page 4…Predicate 510(k) Predicate Equivalent Devices: Number Manufacturer / Model XLTEK / Comet-PLUS® K021807 Grass-Telefactor Product Group, Astro-… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180290 | Natus Brain Monitor Amplifier | 2018 | 1 |
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 17 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K180290 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021807.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172711: Comet-PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172711
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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