510(k) Report

510(k) · Cleared

Cleared

A-1000 Eeg Monitor and a-1050 Eeg Monitor

K963644510(k) TraditionalCleared Oct 8, 199626-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

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

Cleared on Oct 8, 1996 after a 26-day review. The FDA summary names no predicate by number. 340 later devices descend from it.

Decided
Oct 8, 1996
Review
26 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
0

340 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1998: 2 descendants cleared2015: 11 descendants cleared2007: 8 descendants cleared2014: 13 descendants cleared2024: 23 descendants cleared2021: 14 descendants cleared2023: 27 descendants cleared2026: 16 descendants cleared2004: 5 descendants cleared2008: 12 descendants cleared2001: 1 descendant cleared2003: 4 descendants cleared2005: 9 descendants cleared2020: 15 descendants cleared2019: 16 descendants cleared2010: 11 descendants cleared2018: 17 descendants cleared2002: 1 descendant cleared2009: 7 descendants cleared2016: 15 descendants cleared2012: 11 descendants cleared2025: 27 descendants cleared2006: 11 descendants cleared2013: 14 descendants cleared2017: 14 descendants cleared2022: 22 descendants cleared2011: 12 descendants cleared1995200020052010201520202025
  1. This deviceK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
  2. Descendant · cites it directly · 337 of its ownK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
  3. Descendant · 2 generations on · 305 of its ownK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
  4. Descendant · 3 generations on · 304 of its ownK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
  5. Descendant · 4 generations on · 303 of its ownK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
  6. Descendant · 5 generations on · 274 of its ownK040183 BISXAspect Medical Systems, Inc. · 2004

Showing 5 of 340 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22001: 12002: 12003: 42004: 52005: 92006: 112007: 82008: 122009: 72010: 112011: 122012: 112013: 142014: 132015: 112016: 152017: 142018: 172019: 162020: 152021: 142022: 222023: 272024: 232025: 272026: 16
1998high 27 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 340 · See all
  • K974496A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998 · cites it directly337descendants
  • K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001 · 2 generations on305descendants
  • K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003 · 3 generations on304descendants
  • K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004 · 4 generations on303descendants
  • K040183BISXAspect Medical Systems, Inc. · 2004 · 5 generations on274descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963644A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc.1996—
+1K974496A-2000 Eeg Monitor with BisAspect Medical Systems, Inc.1998—
+2K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn2001—
+3K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2003—
+4K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2004—
+5K040183BISXAspect Medical Systems, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200110
200210
200340
200450
200590
2006110
200780
2008120
200970
2010110
2011120
2012110
2013140
2014130
2015110
2016150
2017140
2018170
2019160
2020150
2021140
2022220
2023270
2024230
2025270
2026160
FIG. 1 — Lineage of K963644, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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?

The FDA summary names no predicate by number.

What descends from it? (340)

See all 340

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

NumberDeviceApplicantDecidedDescendants
K974496A-2000 Eeg Monitor with BisAspect Medical Systems, Inc.1998337
K973596Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc.199830
K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc.20078
K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150
K991012Siemens Infinity Eeg PodSiemens Medical Solutions USA, Inc.19990

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, K974496 (Aspect Medical Systems, Inc., 1998) has gone furthest, with 337 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—

What is it indicated for?

The Aspect EEG Monitors with BIS are intended to monitor the state of the brain by data

acquisition of EEG signals in the intensive care unit, operating room and for clinical research.

The Bispectral Index (BIS), a processed EEG varisble, may be used as an aid in monitoring the

effects of certain anesthetic agents.

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

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 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/K963644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963644

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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