510(k) Report

510(k) · Cleared

Cleared

Spacelabs Medical Model 90481 Eeg Module

K932842510(k) TraditionalCleared Mar 2, 1994264-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

Spacelabs Medical, Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Mar 2, 1994 after a 264-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 410 later devices descend from it.

Decided
Mar 2, 1994
Review
264 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2002: 2 descendants cleared2001: 1 descendant cleared2007: 6 descendants cleared2010: 20 descendants cleared2005: 9 descendants cleared2006: 14 descendants cleared2009: 15 descendants cleared2003: 4 descendants cleared2011: 19 descendants cleared2004: 9 descendants cleared2012: 19 descendants cleared2008: 14 descendants cleared2015: 14 descendants cleared2013: 17 descendants cleared2016: 16 descendants cleared2017: 17 descendants cleared2018: 25 descendants cleared2014: 14 descendants cleared2021: 18 descendants cleared2020: 14 descendants cleared2023: 26 descendants cleared2022: 28 descendants cleared2019: 17 descendants cleared2025: 28 descendants cleared2024: 24 descendants cleared2026: 19 descendants cleared1990200020102020
  1. This deviceK932842 Spacelabs Medical Model 90481 Eeg ModuleSpacelabs Medical, Inc. · 1994
  2. Descendant · cites it directly · 409 of its ownK992674 HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH · 1999
  3. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  4. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  5. Descendant · 3 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  6. Descendant · 3 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003

Showing 5 of 410 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 22003: 42004: 92005: 92006: 142007: 62008: 142009: 152010: 202011: 192012: 192013: 172014: 142015: 142016: 162017: 172018: 252019: 172020: 142021: 182022: 282023: 262024: 242025: 282026: 19
1999high 28 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 410 · See all
  • K992674HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH · 1999 · cites it directly409descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 3 generations on404descendants
  • K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on376descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932842Spacelabs Medical Model 90481 Eeg ModuleSpacelabs Medical, Inc.1994—
+1K992674HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH1999—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
+3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200220
200340
200490
200590
2006140
200760
2008140
2009150
2010200
2011190
2012190
2013170
2014140
2015140
2016160
2017170
2018250
2019170
2020140
2021180
2022280
2023260
2024240
2025280
2026190
FIG. 1 — Lineage of K932842, 1994–2026Source: 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 GWQ? 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 GWQ device

  1. #1 K260455 New Wave Systemscore 13.7 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (410)

See all 410

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

NumberDeviceApplicantDecidedDescendants
K992674HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH1999409

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, K992674 (Hewlett-Packard GmbH, 1999) has gone furthest, with 409 descendants of its own.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007: 12008: 22010: 32011: 42012: 42013: 22014: 22015: 32016: 32017: 52018: 82020: 62022: 32023: 62024: 12026 (partial year): 2
2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2010: 73 days median2011: 220 days median2012: 208 days median2015: 276 days median2016: 50 days median2017: 181 days median2018: 150 days median2020: 216 days median2022: 216 days median2023: 137 days median
2007high 276 (2015) · low 50 (2016)2026

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

Recalls per year · GWQ

1in 2020

2007: 52008: 22009: 12010: 12015: 22019: 22020: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWQ

13in 2025

2007: 112008: 82009: 72010: 122011: 62012: 92013: 42014: 72015: 132016: 282017: 172018: 152019: 162020: 302021: 202022: 162023: 202024: 172025: 13
2007high 30 (2020) · low 4 (2013)2025

MAUDE reports naming product code GWQ, 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—511
20082—28
20090—17
2010373112
2011422006
2012420809
20132—04
20142—07
20153276213
2016350028
20175181017
20188150015
20190—216
20206216130
20210—020
20223216016
20236137020
20241—017
20250—013
20262—1—

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https://510kreport.com/device/K932842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932842: Spacelabs Medical Model 90481 Eeg Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932842

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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