510(k) · Cleared
ClearedAspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110
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 Sep 27, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Sep 27, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK001980 Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110Aspect Medical Systems, Inc. · 2000
- Descendant · cites it directly · 10 of its ownK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
- Descendant · 2 generations on · 8 of its ownK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
- Descendant · 3 generations on · 7 of its ownK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
- Descendant · cites it directly · 7 of its ownK041670 Bis Pediatric SensorAspect Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK143506 Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi…Covidien · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002 · cites it directly10descendants
- K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003 · 2 generations on8descendants
- K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005 · 3 generations on7descendants
- K041670Bis Pediatric SensorAspect Medical Systems, Inc. · 2004 · cites it directly7descendants
- K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Covidien · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001980 | Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110 | Aspect Medical Systems, Inc. | 2000 | — |
| +1 | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories | Datex-Ohmeda | 2002 | — |
| +2 | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories | Datex-Ohmeda | 2003 | — |
| +3 | K050835 | Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories | GE Healthcare | 2005 | — |
| +1 | K041670 | Bis Pediatric Sensor | Aspect Medical Systems, Inc. | 2004 | — |
| +2 | K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3… | Covidien | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 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?
- Of its descendants, K013389 (Datex-Ohmeda, 2002) has gone furthest, with 10 descendants 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.
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 | — |
https://510kreport.com/device/K001980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001980: Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001980
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026