510(k) · Cleared
ClearedBis Quatro Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspect Medical Systems, Inc. · GXY Electrode, Cutaneous
Cleared on Oct 23, 2009 as substantially equivalent to K002734 (Aspect Medical Systems, Inc., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002734 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002734 Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc. · 2000
- This deviceK093183 Bis Quatro SensorAspect Medical Systems, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK143506 Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi…Covidien · 2015
- Descendant · 2 generations on · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK241160 CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK240668 Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK222671 DeltaScan PatchProlira B.V. · 2023
Most influential descendants
Showing 5 of 5 · See all- K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Covidien · 2015 · cites it directly4descendants
- K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · 2 generations on1descendant
- K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024 · 2 generations on0descendants
- K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024 · 3 generations on0descendants
- K222671DeltaScan PatchProlira B.V. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002734 | Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 | Aspect Medical Systems, Inc. | 2000 | — |
| 0 (this device) | K093183 | Bis Quatro Sensor | Aspect Medical Systems, Inc. | 2009 | — |
| +1 | K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3… | Covidien | 2015 | — |
| +2 | K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023 | — |
| +2 | K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024 | — |
| +3 | K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024 | — |
| +2 | K222671 | DeltaScan Patch | Prolira B.V. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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 |
|---|---|---|---|
| * | K002734 | Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Summary page 1…ood, Drug and Cosmetic Act for cutaneous electrodes. (21 CFR 882.1320). 6. Predicate Device Aspect Medical Systems Enhanced BIS Sensor This 5 10(k), # K002734, received FDA clearance on September 14, 2000 7. Device Description This 510(k) is being submitted for the BIS Quatro wh… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes… | 2015 | 4 |
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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093183: Bis Quatro Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093183
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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