510(k) Report

510(k) · Cleared

Cleared

Spacelabs Medical Ecg Module (Model 90492)

K942058510(k) TraditionalCleared May 17, 1995383-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spacelabs Medical, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on May 17, 1995 after a 383-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 152 later devices descend from it.

Decided
May 17, 1995
Review
383 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

152 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared2002: 1 descendant cleared2005: 3 descendants cleared1999: 1 descendant cleared2006: 6 descendants cleared2000: 1 descendant cleared2010: 10 descendants cleared2007: 4 descendants cleared2003: 1 descendant cleared2009: 10 descendants cleared2011: 5 descendants cleared2012: 6 descendants cleared2008: 7 descendants cleared2004: 2 descendants cleared2014: 9 descendants cleared2015: 10 descendants cleared2013: 7 descendants cleared2018: 8 descendants cleared2017: 9 descendants cleared2016: 7 descendants cleared2019: 7 descendants cleared2021: 5 descendants cleared2024: 6 descendants cleared2020: 2 descendants cleared2022: 7 descendants cleared2023: 7 descendants cleared2026: 5 descendants cleared2025: 3 descendants cleared1995200020052010201520202025
  1. This deviceK942058 Spacelabs Medical Ecg Module (Model 90492)Spacelabs Medical, Inc. · 1995
  2. Descendant · cites it directly · 150 of its ownK952912 Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997
  3. Descendant · cites it directly · 150 of its ownK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
  4. Descendant · cites it directly · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
  5. Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  6. Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004

Showing 5 of 152 descendants. See all descendants

Descendants cleared per year

1997: 21998: 11999: 12000: 12002: 12003: 12004: 22005: 32006: 62007: 42008: 72009: 102010: 102011: 52012: 62013: 72014: 92015: 102016: 72017: 92018: 82019: 72020: 22021: 52022: 72023: 72024: 62025: 32026: 5
1997high 10 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 152 · See all
  • K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997 · cites it directly150descendants
  • K962970Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997 · cites it directly150descendants
  • K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · cites it directly149descendants
  • K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 2 generations on119descendants
  • K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 3 generations on88descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942058Spacelabs Medical Ecg Module (Model 90492)Spacelabs Medical, Inc.1995—
+1K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997—
+1K962970Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc.1997—
+1K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.19983
+2K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001
+3K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
199910
200010
200210
200310
200420
200530
200660
200740
200870
2009100
2010100
201150
201260
201370
201490
2015100
201670
201790
201880
201970
202020
202150
202270
202370
202460
202530
202650
FIG. 1 — Lineage of K942058, 1995–2026Source: 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 DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (152)

See all 152

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

NumberDeviceApplicantDecidedDescendants
K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997150
K962970Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc.1997150
K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.1998149

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, K952912 (Spacelabs Medical, Inc., 1997) has gone furthest, with 150 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

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

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

More from Spacelabs Medical, Inc.

35 FDA decisions under this applicant name. See the company

  • K120616Spacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. · 20129 recalls
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  • K102422Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 20103 recalls
  • K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 20092 recalls
  • K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 20081 recall

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The DSI category page

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https://510kreport.com/device/K942058 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942058: Spacelabs Medical Ecg Module (Model 90492).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942058

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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