510(k) Report

510(k) · Cleared

Cleared

Aspect Medical Systems Eeg Sensor, Model 186-0076

K994330510(k) SpecialCleared Jan 18, 200026-day reviewClass II21 CFR 882.1320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aspect Medical Systems, Inc. · GXY Electrode, Cutaneous

Cleared on Jan 18, 2000 as substantially equivalent to K961821 (Aspect Medical Systems, Inc., 1996) after a 26-day review. Its family tree reaches back 2 generations to 1977. 11 later devices descend from it.

Decided
Jan 18, 2000
Review
26 days
Class
Class II
Product code
GXY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K761301 (1977). 3 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2002: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2007: 1 descendant cleared2008: 2 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant clearedK761301 · V-Trace Ecg Backpad · Ndm Corp. · 1977K961821 · Aspect Medical Systems Zipprep Eeg Sensor · Aspect Medical Systems, Inc. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants K961821 · Aspect Medical Systems Zipprep Eeg Sensor · Aspect Medical Systems, Inc. · 1996K761301 · V-Trace Ecg Backpad · Ndm Corp. · 19770+5
  1. Root · 2 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. 1 generation backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. This deviceK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. Descendant · cites it directly · 10 of its ownK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. Descendant · 2 generations on · 8 of its ownK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. Descendant · 3 generations on · 7 of its ownK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
  7. Descendant · 3 generations on · 4 of its ownK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
  8. Descendant · 4 generations on · 2 of its ownK061907 Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and…GE Healthcare · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 22007: 12008: 22011: 12015: 12023: 12024: 1
2002high 2 (2005) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · 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
  • K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007 · 3 generations on4descendants
  • K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2008 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K761301V-Trace Ecg BackpadNdm Corp.1977—
−1K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.1996—
0 (this device)K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.2000—
+1K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda2002—
+2K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda2003—
+3K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare2005—
+3K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare2007—
+4K061907Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesGE Healthcare2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200520
200710
200820
201110
201510
202310
202410
FIG. 1 — Lineage of K994330, 1977–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K961821Aspect Medical Systems Zipprep Eeg Sensor
Summary page 1
…ave been classified by the Neurological Devices Panel as Class II devices. Refer to 21 CFR 882.1320. Predicate Device Aspect Medical Systems Zipprep EEG Sensor 510(k) #K961821, clearance date 10/4/96 Description The Aspect Medical Systems, Inc. EEG Sensor (hereafter referred to as the Aspect Sensor, As…
Aspect Medical Systems, Inc.1996—

Also cleared against K961821: 1 other device →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda200210

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 23 years and passes through 2 companies; a new generation was cleared every 19.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K013389 (Datex-Ohmeda, 2002) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K961821.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXY

6in 2025

2007: 72008: 92009: 172010: 32011: 62012: 92013: 72014: 92015: 62016: 62017: 92018: 142019: 92020: 42021: 122022: 52023: 132024: 72025: 62026 (partial year): 12
2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007: 88 days median2008: 136 days median2009: 159 days median2010: 137 days median2011: 183 days median2012: 150 days median2013: 99 days median2014: 203 days median2015: 119 days median2016: 170 days median2017: 116 days median2018: 135 days median2019: 113 days median2020: 108 days median2021: 195 days median2022: 81 days median2023: 132 days median2024: 111 days median2025: 148 days median2026 (partial year): 70 days median
2007high 203 (2014) · low 81 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXY

2in 2023

2009: 42010: 12011: 52012: 42023: 2
2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXY

58in 2025

2007: 142008: 172009: 152010: 142011: 162012: 162013: 152014: 112015: 192016: 152017: 112018: 102019: 192020: 112021: 212022: 342023: 252024: 512025: 58
2007high 58 (2025) · low 10 (2018)2025

MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007788014
20089136017
200917159415
20103137114
20116183516
20129150416
2013799015
20149203011
20156119019
20166170015
20179116011
201814135010
20199113019
20204108011
202112195021
2022581034
202313132225
20247111051
20256148058
202612700—

What is it indicated for?

The EEG Sensor (BIS Sensor +) is applied directly to the patient's skin to enable recording 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.

Also cleared against K961821

1 other device cites the same predicate.

  • K070069Zipprep ElectrodeAspect Medical Systems, Inc. · 2007

More from Aspect Medical Systems, Inc.

25 FDA decisions under this applicant name. See the company

  • K093183Bis Quatro SensorAspect Medical Systems, Inc. · 2009
  • K091854Bis Click Sensor/CableAspect Medical Systems, Inc. · 2009
  • K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 20071 recall
  • K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
  • K070069Zipprep ElectrodeAspect Medical Systems, Inc. · 2007

Recent decisions in GXY

The GXY category page

  • K262664Rongjian Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd. · 2026
  • K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026
  • K261522BioWave BioWrapsBiowave Corporation · 2026

https://510kreport.com/device/K994330 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994330: Aspect Medical Systems Eeg Sensor, Model 186-0076.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994330

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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