510(k) · Cleared
ClearedNatus Quantum
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 Feb 22, 2018 as substantially equivalent to K143440 (Natus Medical Incorporated, 2015) after a 30-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Feb 22, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040360 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040360 EMU128S, Model EX-NW-128SExcel Tech., Ltd. · 2004
- 1 generation backK143440 Natus QuantumNatus Medical Incorporated · 2015 · Recalled
- This deviceK180181 Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · 2018
- Descendant · cites it directly · 0 of its ownK181466 Cadwell Zenith SystemCadwell Industries, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K040360 | EMU128S, Model EX-NW-128S | Excel Tech., Ltd. | 2004 | — |
| −1 | K143440 | Natus Quantum | Natus Medical Incorporated | 2015 | 1 |
| 0 (this device) | K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018 | — |
| +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 | 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? (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 |
|---|---|---|---|
| * | K143440 | Natus QuantumSummary page 4…ber Manufacturer / Model Natus Medical Natus Quantum K143440 Incorporated DBA… | 2015 |
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 |
|---|---|---|---|
| K181466 | Cadwell Zenith System | 2018 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181466 (Cadwell Industries, Inc., 2018) 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 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 as stated in the FDA summary.
https://510kreport.com/device/K180181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180181: Natus Quantum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180181
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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