510(k) · Cleared
Recalled · Class II · 2015Natus Quantum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 20, 2015 as substantially equivalent to K040360 (Excel Tech., Ltd., 2004) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 20, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040360 (2004). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK040360 EMU128S, Model EX-NW-128SExcel Tech., Ltd. · 2004
- This deviceK143440 Natus QuantumNatus Medical Incorporated · 2015
- Descendant · cites it directly · 1 of its ownK180290 Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK180181 Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · 2018
- Descendant · 2 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK181466 Cadwell Zenith SystemCadwell Industries, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · cites it directly1descendant
- K180181Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · 2018 · cites it directly1descendant
- K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020 · 2 generations on0descendants
- K181466Cadwell Zenith SystemCadwell Industries, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040360 | EMU128S, Model EX-NW-128S | Excel Tech., Ltd. | 2004 | — |
| 0 (this device) | K143440 | Natus Quantum | Natus Medical Incorporated | 2015 | — |
| +1 | K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | 1 |
| +1 | K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018 | — |
| +2 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
| +1 | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 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 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? (2)
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 |
|---|---|---|---|
| * | K040360 | EMU128S, Model EX-NW-128SSummary page 4…Regulation Number : 21CFR 882.1400 Classification Name: Full-montage standard electroencephalograph Product code: GWQ, OLV Device Class: Il Predicate Device: EMU128 (K040360); Neurolink IP 256 (K100683) Description: 1. Overview: Natus Quantum Amplifier The Natus Quantum Amplifier is intended to be… | 2004 |
| * | K100683 | Neurolink IP Model: PK1117Summary page 4…2.1400 Classification Name: Full-montage standard electroencephalograph Product code: GWQ, OLV Device Class: Il Predicate Device: EMU128 (K040360); Neurolink IP 256 (K100683) Description: 1. Overview: Natus Quantum Amplifier The Natus Quantum Amplifier is intended to be used as an electroencephalog… | 2010 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0581-2016 | Software Manufacturing/Software Deployment | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Quantum 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 amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital…
Read the full statement (148 words)
The Natus Quantum 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 amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.
The Natus Quantum 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143440: Natus Quantum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143440
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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