510(k) · Cleared

Cleared

Cerebral State Monitor - CSM

K042315510(k) TraditionalCleared Jan 21, 2005148-day reviewClass II21 CFR 882.1400

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

Danmeter A/S · OLW Index-Generating Electroencephalograph Software

Cleared on Jan 21, 2005 as substantially equivalent to K010965 (Alaris Medical Systems, Inc., 2001) and 1 other predicate after a 148-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jan 21, 2005
Review: 148 days
Class: Class II
Product code: OLW
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K963644 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
1 generation backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
This deviceK042315 Cerebral State Monitor - CSMDanmeter A/S · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963644	A-1000 Eeg Monitor and a-1050 Eeg Monitor	Aspect Medical Systems, Inc.	1996	—
−1	K974496	A-2000 Eeg Monitor with Bis	Aspect Medical Systems, Inc.	1998	—
0 (this device)	K042315	Cerebral State Monitor - CSM	Danmeter A/S	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K042315, 1996–2005Source: 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 OLW? 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 OLW device

#1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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
*	K010965	A-Line Aep Monitor Our OCR of the scanned summary read K010865, FDA’s number for Amsco Century Medium Sterilizer, Model Century (STERIS Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AEP Monitor”.	Alaris Medical Systems, Inc.	2001	—
*	K974496	A-2000 Eeg Monitor with Bis Summary page 1 …te devices: Predicate Device Manufacturer 510(k) No. Date Cleared AEP Monitor Danmeter A/S K010865 6/27/2001 (Reg. by: Alaris Medical Systems) A-2000 EEG Aspect Medical K974496 2/6/1998 Monitor with BIS Systems Danmeter A/S Original Premarket 510(k) Notification Canrtinn C Dnana 1 AF9 Ce…	Aspect Medical Systems, Inc.	1998	—

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 9 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All OLW devices

OLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLW

1in 2024

2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLW

105in 2007

2007high 105 (2007)2026

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

Recalls per year · OLW

No recall names OLW since 2007.

Adverse event reports per year · OLW

73in 2025

2007high 93 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	3	105	0
2008	2	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	3
2018	1	—	3
2019	0	—	6
2020	0	—	15
2021	1	—	15
2022	1	—	27
2023	1	—	18
2024	1	—	93
2025	0	—	73
2026	2	—	—

What is it indicated for?

The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K042315 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042315: Cerebral State Monitor - CSM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042315

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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