510(k) · Cleared

Cleared

Bis Pediatric Sensor

K041670510(k) SpecialCleared Jul 6, 200415-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 Jul 6, 2004 as substantially equivalent to K001980 (Aspect Medical Systems, Inc., 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided: Jul 6, 2004
Review: 15 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

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

By dateBy generation

Root · 1 generation backK002734 Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc. · 2000
This deviceK041670 Bis Pediatric SensorAspect Medical Systems, Inc. · 2004
Descendant · cites it directly · 4 of its ownK143506 Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi…Covidien · 2015
Descendant · 2 generations on · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
Descendant · cites it directly · 1 of its ownK151576 Neon EEGIncereb, Ltd. · 2015
Descendant · 2 generations on · 0 of its ownK243788 IceCap product lineBioserenity Medical Devices Group · 2025
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

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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002734	Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106	Aspect Medical Systems, Inc.	2000	—
0 (this device)	K041670	Bis Pediatric Sensor	Aspect Medical Systems, Inc.	2004	—
+1	K143506	Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3…	Covidien	2015	—
+2	K220448	Disposable Non-invasive EEG Sensor	Shenzhen Med-Link Electronics Tech Co., Ltd.	2023	—
+1	K151576	Neon EEG	Incereb, Ltd.	2015	—
+2	K243788	IceCap product line	Bioserenity Medical Devices Group	2025	—
+2	K241160	CAIs Sensor (CAIs-001)	Brainu Co., Ltd.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2023	2	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K041670, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K001980	Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110 Summary page 1 …BIS Pediatric Sensor Common Name: Electrode, Cutaneous Electrode Classification: Class II device. Refer to 21 CFR 882.1320 Predicate Devices: K001980, Aspect Pediatric EEG BIS Sensor cleared September 27, 2000 and K002734, Aspect Enhanced XP BIS Sensor cle…	Aspect Medical Systems, Inc.	2000	—
*	K002734	Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 Summary page 1 …: Class II device. Refer to 21 CFR 882.1320 Predicate Devices: K001980, Aspect Pediatric EEG BIS Sensor cleared September 27, 2000 and 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 K001980: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K143506	Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…	Covidien	2015	4
K151576	Neon EEG	Incereb, Ltd.	2015	1

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, K143506 (Covidien, 2015) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K001980.

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

2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007high 203 (2014) · low 81 (2022)2026

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

Recalls per year · GXY

2in 2023

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

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

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 Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041670 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041670: Bis Pediatric Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041670

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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