510(k) Report

510(k) · Cleared

Recalled · 2011

Bis Bilateral Sensor

K062692510(k) SpecialCleared Dec 13, 200693-day reviewClass II21 CFR 882.1320Recalls 1

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 Dec 13, 2006 as substantially equivalent to K002734 (Aspect Medical Systems, Inc., 2000) after a 93-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it. It has been recalled once.

Decided
Dec 13, 2006
Review
93 days
Class
Class II
Product code
GXY
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K002734 (2000). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2023: 2 descendants cleared2024: 2 descendants cleared2025: 1 descendant clearedK002734 · Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 · Aspect Medical Systems, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K002734 · Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 · Aspect Medical Systems, Inc. · 20000
  1. Root · 1 generation backK002734 Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc. · 2000
  2. This deviceK062692 Bis Bilateral SensorAspect Medical Systems, Inc. · 2006
  3. Descendant · cites it directly · 4 of its ownK143506 Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi…Covidien · 2015
  4. Descendant · 2 generations on · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
  5. Descendant · cites it directly · 1 of its ownK151576 Neon EEGIncereb, Ltd. · 2015
  6. Descendant · 2 generations on · 0 of its ownK243788 IceCap product lineBioserenity Medical Devices Group · 2025
  7. Descendant · 2 generations on · 0 of its ownK241160 CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 22023: 22024: 22025: 1
2015high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · 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
  • K151576Neon EEGIncereb, Ltd. · 2015 · cites it directly1descendant
  • K243788IceCap product lineBioserenity Medical Devices Group · 2025 · 2 generations on0descendants
  • K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002734Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc.2000—
0 (this device)K062692Bis Bilateral SensorAspect Medical Systems, Inc.2006—
+1K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3…Covidien2015—
+2K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd.2023—
+1K151576Neon EEGIncereb, Ltd.2015—
+2K243788IceCap product lineBioserenity Medical Devices Group2025—
+2K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
202320
202420
202510
FIG. 1 — Lineage of K062692, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K002734Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106
Summary page 1
…Electrode, Cutaneous Electrode Classification: Class 1I device. Refer to 21 CFR 882.1320 Product Code: GXY Predicate Device: K002734, Aspect Enhanced XP BIS Sensor cleared September 14, 2000 Device Description: The Sensor is a single…
Aspect Medical Systems, Inc.2000—

Also cleared against K002734: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K143506Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Covidien20154
K151576Neon EEGIncereb, Ltd.20151

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2011Not classifiedZ-0802-2012Finished device change controlDuring manufacture, circuit traces were reversed which causes inaccurate display of information.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K143506 (Covidien, 2015) has gone furthest, with 4 descendants of its own.
  • 5 other devices also cite its predicate K002734.

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 BIS Bilateral 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.

Also cleared against K002734

5 other devices cite the same predicate.

  • K093183Bis Quatro SensorAspect Medical Systems, Inc. · 2009
  • K091854Bis Click Sensor/CableAspect Medical Systems, Inc. · 2009
  • K050313Bis SRS (Semi-Resuable Sensor)Aspect Medical Systems, Inc. · 2005
  • K041670Bis Pediatric SensorAspect Medical Systems, Inc. · 2004
  • K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002

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/K062692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062692: Bis Bilateral Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062692

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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