510(k) Report

510(k) · Cleared

Cleared

Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and Accessories

K000892510(k) TraditionalCleared Jun 16, 200088-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

Datex-Ohmeda, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software

Cleared on Jun 16, 2000 after an 88-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
Jun 16, 2000
Review
88 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 2005: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK000892 Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg…Datex-Ohmeda, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK051883 Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox…GE Healthcare · 2005
  3. Descendant · 2 generations on · 0 of its ownK191322 E-Eegx, N-EegxGE Healthcare Finland Oy · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K051883Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and…GE Healthcare · 2005 · cites it directly1descendant
  • K191322E-Eegx, N-EegxGE Healthcare Finland Oy · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000892Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and…Datex-Ohmeda, Inc.2000—
+1K051883Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and…GE Healthcare2005—
+2K191322E-Eegx, N-EegxGE Healthcare Finland Oy2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
202010
FIG. 1 — Lineage of K000892, 2000–2020Source: 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
K051883Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and…GE Healthcare20051

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, K051883 (GE Healthcare, 2005) 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 Datex-Ohmeda, Inc.

59 FDA decisions under this applicant name. See the company

  • K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026
  • K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls
  • K210384Carescape R860Datex-Ohmeda, Inc. · 2021
  • K172702Tec 820, Tec 850Datex-Ohmeda, Inc. · 20184 recalls

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/K000892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000892: Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000892

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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