510(k) · Cleared
Recalled · Class II · 2025Natus Brain Monitor Amplifier
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) · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 14, 2018 as substantially equivalent to K143440 (Natus Medical Incorporated, 2015) and 2 other predicates after a 133-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 14, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K992283 (1999). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK992283 Artisan Acquisition System for Eeg and PolysomnographyAirsep Corp. · 1999
- 2 generations backK024322 Embla N7000Medcare Flaga · 2003
- 1 generation backK111742 MdriveEmbla Systems · 2011
- This deviceK180290 Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018
- Descendant · cites it directly · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
Most influential descendants
Showing 1 of 1 · See all- K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992283 | Artisan Acquisition System for Eeg and Polysomnography | Airsep Corp. | 1999 | — |
| −2 | K024322 | Embla N7000 | Medcare Flaga | 2003 | — |
| −1 | K111742 | Mdrive | Embla Systems | 2011 | — |
| 0 (this device) | K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | — |
| +1 | 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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 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? (3)
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 |
|---|---|---|---|
| * | K143440 | Natus QuantumSummary page 4…CFR 882.1400 Classification Name: Standard Polysomnograph with Electroencephalograph Product code: GWQ, OLV Device Class: II Predicate Device: Natus Quantum (K143440); N7000 System (K111742), Comet-Plus (K172711) Description: 1. Overview: Natus Brain Monitor The Natus Brain Monitor fa… | 2015 |
| * | K111742 | MdriveSummary page 4…cation Name: Standard Polysomnograph with Electroencephalograph Product code: GWQ, OLV Device Class: II Predicate Device: Natus Quantum (K143440); N7000 System (K111742), Comet-Plus (K172711) Description: 1. Overview: Natus Brain Monitor The Natus Brain Monitor family of amplifiers are i… | 2011 |
| * | K172711 | Comet-PLUSSummary page 4…lysomnograph with Electroencephalograph Product code: GWQ, OLV Device Class: II Predicate Device: Natus Quantum (K143440); N7000 System (K111742), Comet-Plus (K172711) Description: 1. Overview: Natus Brain Monitor The Natus Brain Monitor family of amplifiers are intended to be used as an… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193159 | NeuroAmp II, NeuroAmp II.5s | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2025 | Class II | Z-2138-2025 | Process control | Natus received two complaints of left side labeling show impedance for right side. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K193159 (Corscience GmbH & Co. KG, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143440.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180290: Natus Brain Monitor Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180290
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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