510(k) Report

510(k) · Cleared

Cleared

A-1050 Eeg Monitor

K952347510(k) TraditionalCleared Jan 16, 1996242-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. · OLT Non-Normalizing Quantitative Electroencephalograph Software

Cleared on Jan 16, 1996 after a 242-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 16, 1996
Review
242 days
Class
Class II
Product code
OLT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952347 A-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK020218 Snap Eeg MonitorNicolet Biomedical, Inc. · 2002
  3. Descendant · 2 generations on · 0 of its ownK060997 Snap II Eeg MonitorEverest Biomedical Instruments Co. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K020218Snap Eeg MonitorNicolet Biomedical, Inc. · 2002 · cites it directly1descendant
  • K060997Snap II Eeg MonitorEverest Biomedical Instruments Co. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952347A-1050 Eeg MonitorAspect Medical Systems, Inc.1996—
+1K020218Snap Eeg MonitorNicolet Biomedical, Inc.2002—
+2K060997Snap II Eeg MonitorEverest Biomedical Instruments Co.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
FIG. 1 — Lineage of K952347, 1996–2006Source: 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 OLT? 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 OLT device

  1. #1 K253767 UB ERP Systemscore 14.9 · 12 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K020218Snap Eeg MonitorNicolet Biomedical, Inc.20021

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, K020218 (Nicolet Biomedical, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All OLT devices

OLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLT

2in 2025

2007: 12008: 22009: 22013: 12014: 12015: 52019: 22020: 12022: 22024: 12025: 22026 (partial year): 3
2007high 5 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLT

266in 2015

2015: 266 days median2026 (partial year): 217 days median
2007high 266 (2015)2026

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

Recalls per year · OLT

No recall names OLT since 2007.

Adverse event reports per year · OLT

3in 2025

2016: 12017: 22018: 72019: 22020: 12021: 62022: 42023: 52024: 42025: 3
2007high 7 (2018) · low 0 (2007)2025

MAUDE reports naming product code OLT, 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
20071—00
20082—00
20092—00
20100—00
20110—00
20120—00
20131—00
20141—00
2015526600
20160—01
20170—02
20180—07
20192—02
20201—01
20210—06
20222—04
20230—05
20241—04
20252—03
202632170—

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 OLT

The OLT category page

  • K261712Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
  • K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
  • K253767UB ERP SystemUniversal Brain · 2026
  • K251881HippoMind (v1.0)Hippoclinic · 2025
  • K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator…Nihon Kohden Corporation · 2025

https://510kreport.com/device/K952347 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952347: A-1050 Eeg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952347

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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