510(k) · Cleared

Cleared

Bis Click Sensor/Cable

K091854510(k) TraditionalCleared Jul 2, 200913-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 2, 2009 as substantially equivalent to K050313 (Aspect Medical Systems, Inc., 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jul 2, 2009
Review: 13 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K940802 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK940802 Zipprep ElectrodeAspect Medical Systems, Inc. · 1994
1 generation backK050313 Bis SRS (Semi-Resuable Sensor)Aspect Medical Systems, Inc. · 2005
This deviceK091854 Bis Click Sensor/CableAspect Medical Systems, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K940802	Zipprep Electrode	Aspect Medical Systems, Inc.	1994	—
−1	K050313	Bis SRS (Semi-Resuable Sensor)	Aspect Medical Systems, Inc.	2005	—
0 (this device)	K091854	Bis Click Sensor/Cable	Aspect Medical Systems, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K091854, 1994–2009Source: 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

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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
*	K050313	Bis SRS (Semi-Resuable Sensor) Summary page 1 …514 of the Food, Drug and Cosmetic Act for cutaneous electrodes. (21 CFR 882.1320). 6. Predicate Device Aspect Medical Systems BIS SRS This 510(k), #K050313, received FDA clearance on February 24, 2005 Aspect Medical Systems Enhanced BIS Sensor This 510(k), # K002734, receiv…	Aspect Medical Systems, Inc.	2005	—
*	K002734	Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 Summary page 1 …pect Medical Systems BIS SRS This 510(k), #K050313, received FDA clearance on February 24, 2005 Aspect Medical Systems Enhanced BIS Sensor This 510(k), # K002734, received FDA clearance on September 14, 2000 7. Device Description The BIS Click Sensor is a system comprised of the BI…	Aspect Medical Systems, Inc.	2000	—

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 1 company; a new generation was cleared every 10.7 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 Click 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.

https://510kreport.com/device/K091854 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091854: Bis Click Sensor/Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091854

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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