510(k) Report

510(k) · Cleared

Cleared

Aspect Medical Systems Zipprep Eeg Sensor

K961821510(k) TraditionalCleared Oct 4, 1996147-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 Oct 4, 1996 as substantially equivalent to K940802 (Aspect Medical Systems, Inc., 1994) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1977. 13 later devices descend from it.

Decided
Oct 4, 1996
Review
147 days
Class
Class II
Product code
GXY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K761301 (1977). 2 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2007: 2 descendants cleared2000: 1 descendant cleared2002: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2008: 2 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant clearedK761301 · V-Trace Ecg Backpad · Ndm Corp. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants K761301 · V-Trace Ecg Backpad · Ndm Corp. · 19770+5
  1. Root · 1 generation backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
  2. This deviceK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. Descendant · cites it directly · 11 of its ownK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. Descendant · 2 generations on · 10 of its ownK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. Descendant · 3 generations on · 8 of its ownK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. Descendant · 4 generations on · 7 of its ownK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
  7. Descendant · 4 generations on · 4 of its ownK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12003: 12005: 22007: 22008: 22011: 12015: 12023: 12024: 1
2000high 2 (2005) · low 0 (2001)2026

Most influential descendants

Showing 5 of 13 · See all
  • K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000 · cites it directly11descendants
  • K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002 · 2 generations on10descendants
  • K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003 · 3 generations on8descendants
  • K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005 · 4 generations on7descendants
  • K062580GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200310
200520
200720
200820
201110
201510
202310
202410
FIG. 1 — Lineage of K961821, 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? (2)

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
*K940802Zipprep Electrode
Summary page 2
…Statement of Substantial Equivalence The Aspect EEG Sensor is substantially equivalent to the following devices: 1) Aspect Medical Systems Zipprep™ Electrode, 510(k) #K940802 2) NDM ECG Backpad, 510(k) #K761301 Similarities 1) The Aspect EEG Sensor is similar to the 510(k) Aspect Zipprep Electrode in…
Aspect Medical Systems, Inc.1994—
*K761301V-Trace Ecg Backpad
Summary page 2
…ce The Aspect EEG Sensor is substantially equivalent to the following devices: 1) Aspect Medical Systems Zipprep™ Electrode, 510(k) #K940802 2) NDM ECG Backpad, 510(k) #K761301 Similarities 1) The Aspect EEG Sensor is similar to the 510(k) Aspect Zipprep Electrode in the following ways: o The indicatio…
Ndm Corp.1977—

Also cleared against K940802: 2 other devices →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.200011
K070069Zipprep ElectrodeAspect Medical Systems, Inc.20070

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K994330 (Aspect Medical Systems, Inc., 2000) has gone furthest, with 11 descendants of its own.
  • 2 other devices also cite its predicate K940802.

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 Aspect EEG Sensor is applied directly to the patient’s skin to enable recording of electro-physiological (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 K940802

2 other devices cite the same predicate.

  • K070069Zipprep ElectrodeAspect Medical Systems, Inc. · 2007
  • K050313Bis SRS (Semi-Resuable Sensor)Aspect Medical Systems, Inc. · 2005

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/K961821 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961821: Aspect Medical Systems Zipprep Eeg Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961821

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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