510(k) Report

510(k) · Cleared

Cleared

Bis Engine

K002837510(k) SpecialCleared Sep 19, 20007-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 Sep 19, 2000 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 307 later devices descend from it.

Decided
Sep 19, 2000
Review
7 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
0

307 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2003: 1 descendant cleared2004: 4 descendants cleared2005: 8 descendants cleared2006: 11 descendants cleared2008: 9 descendants cleared2007: 7 descendants cleared2013: 13 descendants cleared2015: 9 descendants cleared2011: 12 descendants cleared2016: 14 descendants cleared2012: 10 descendants cleared2009: 6 descendants cleared2010: 9 descendants cleared2017: 13 descendants cleared2018: 16 descendants cleared2014: 12 descendants cleared2024: 22 descendants cleared2021: 14 descendants cleared2023: 27 descendants cleared2026: 16 descendants cleared2019: 14 descendants cleared2022: 21 descendants cleared2020: 12 descendants cleared2025: 25 descendants cleared200020052010201520202025
  1. This deviceK002837 Bis EngineAspect Medical Systems, Inc. · 2000
  2. Descendant · cites it directly · 306 of its ownK011834 Bis EngineAspect Medical Systems, Inc. · 2001
  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 307 descendants. See all descendants

Descendants cleared per year

2001: 22003: 12004: 42005: 82006: 112007: 72008: 92009: 62010: 92011: 122012: 102013: 132014: 122015: 92016: 142017: 132018: 162019: 142020: 122021: 142022: 212023: 272024: 222025: 252026: 16
2001high 27 (2023) · low 0 (2002)2026

Most influential descendants

Showing 5 of 307 · See all
  • K011834Bis EngineAspect Medical Systems, Inc. · 2001 · cites it directly306descendants
  • 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)K002837Bis EngineAspect Medical Systems, Inc.2000—
+1K011834Bis EngineAspect Medical Systems, Inc.2001—
+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
200120
200310
200440
200580
2006110
200770
200890
200960
201090
2011120
2012100
2013130
2014120
201590
2016140
2017130
2018160
2019140
2020120
2021140
2022210
2023270
2024220
2025250
2026160
FIG. 1 — Lineage of K002837, 2000–2026Source: 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), 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 17.1 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (307)

See all 307

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

NumberDeviceApplicantDecidedDescendants
K011834Bis EngineAspect Medical Systems, Inc.2001306

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, K011834 (Aspect Medical Systems, Inc., 2001) has gone furthest, with 306 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 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/K002837 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002837: Bis Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002837

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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