510(k) · Cleared
ClearedBis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-XP Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,Cvi-Enabled,2-Channel (4 Electrodes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GXY Electrode, Cutaneous
Cleared on Apr 16, 2015 as substantially equivalent to K093183 (Aspect Medical Systems, Inc., 2009) and 2 other predicates after a 127-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Apr 16, 2015
- Review
- 127 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002734 (2000). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002734 Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc. · 2000
- 1 generation backK041670 Bis Pediatric SensorAspect Medical Systems, Inc. · 2004
- This deviceK143506 Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi…Covidien · 2015
- Descendant · cites it directly · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK241160 CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK240668 Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222671 DeltaScan PatchProlira B.V. · 2023
Most influential descendants
Showing 4 of 4 · See all- K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · cites it directly1descendant
- K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024 · cites it directly0descendants
- K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024 · 2 generations on0descendants
- K222671DeltaScan PatchProlira B.V. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002734 | Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 | Aspect Medical Systems, Inc. | 2000 | — |
| −1 | K041670 | Bis Pediatric Sensor | Aspect Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3… | Covidien | 2015 | — |
| +1 | K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023 | — |
| +1 | K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024 | — |
| +2 | K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024 | — |
| +1 | K222671 | DeltaScan Patch | Prolira B.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K093183 | Bis Quatro Sensor Our OCR of the scanned summary read K093133, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aspect Medical Systems BIS Quatro (and Extend) Sensor”. | 2009 |
| * | K062692 | Bis Bilateral SensorSummary page 4…w owns these technologies. Aspect Medical Systems BIS Quatro (and Extend) Sensor K093133, concurrence date October 23, 2009 Aspect Medical Systems BIS Bilateral Sensor K062692, concurrence date December 13, 2006. Aspect Medical Systems BIS Pediatric Sensor K041670, concurrence date July 6, 2004 A refer… | 2006 |
| * | K041670 | Bis Pediatric SensorSummary page 4…concurrence date October 23, 2009 Aspect Medical Systems BIS Bilateral Sensor K062692, concurrence date December 13, 2006. Aspect Medical Systems BIS Pediatric Sensor K041670, concurrence date July 6, 2004 A reference to multiple predicates is intended to illustrate that the reformulated sensor gel wil… | 2004 |
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)
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 15 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K220448 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.
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/K143506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143506: Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-XP Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,Cvi-Enabled,2-Channel (4 Electrodes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143506
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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