510(k) Report

510(k) · Cleared

Cleared

A-Line Aep Monitor

K010965510(k) TraditionalCleared Jun 27, 200186-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

Alaris Medical Systems, Inc. · OLW Index-Generating Electroencephalograph Software

Cleared on Jun 27, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 27, 2001
Review
86 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared200020052010201520202025
  1. This deviceK010965 A-Line Aep MonitorAlaris Medical Systems, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK042315 Cerebral State Monitor - CSMDanmeter A/S · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K042315Cerebral State Monitor - CSMDanmeter A/S · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010965A-Line Aep MonitorAlaris Medical Systems, Inc.2001—
+1K042315Cerebral State Monitor - CSMDanmeter A/S2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K010965, 2001–2005Source: 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), 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. #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042315Cerebral State Monitor - CSMDanmeter A/S20050

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?

  • Of its descendants, K042315 (Danmeter A/S, 2005) has gone furthest, with 0 descendants of its own.

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

2007: 32008: 22015: 12018: 12021: 12022: 12023: 12024: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLW

105in 2007

2007: 105 days median
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

2017: 32018: 32019: 62020: 152021: 152022: 272023: 182024: 932025: 73
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007310500
20082—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—03
20181—03
20190—06
20200—015
20211—015
20221—027
20231—018
20241—093
20250—073
20262—0—

More from Alaris Medical Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • K043299Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20041 Class I recall
  • K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 20041 Class I recall
  • K031741Medley ETCO2 Module (Includes Accessories), Model 8300Alaris Medical Systems, Inc. · 20042 recalls
  • K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20033 recalls
  • K032147Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX SeriesAlaris Medical Systems, Inc. · 20031 recall

Recent decisions in OLW

The OLW category page

  • K260907BIS™ Advance pEEG ModuleCovidien LP · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024
  • K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd. · 2023
  • K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation · 2022

https://510kreport.com/device/K010965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010965: A-Line Aep Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010965

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026