510(k) Report

510(k) · Cleared

Cleared

Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option

K962970510(k) TraditionalCleared Mar 25, 1997237-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 Mar 25, 1997 as substantially equivalent to K942058 (Spacelabs Medical, Inc., 1995) and 1 other predicate after a 237-day review. Its family tree reaches back 1 generation to 1994. 150 later devices descend from it.

Decided
Mar 25, 1997
Review
237 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K933143 (1994). 2 ancestors in all. 150 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1998: 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 clearedK933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 11 descendants4 generations forward: 14 descendants5 generations forward: 25 descendants6 generations forward: 31 descendants7 generations forward: 22 descendants8 generations forward: 18 descendants9 generations forward: 15 descendants10 generations forward: 5 descendants11 generations forward: 2 descendants K933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 19940+5+10
  1. Root · 1 generation backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
  2. This deviceK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
  3. Descendant · cites it directly · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
  4. Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  5. Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
  6. Descendant · 4 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  7. Descendant · 2 generations on · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

1998: 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
1998high 10 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 150 · See all
  • 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
  • K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 4 generations on87descendants
  • K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · 2 generations on75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933143Model Eli 300 ElectrocardiographMortara Instrument, Inc.1994—
0 (this device)K962970Spacelabs 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—
+4K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+2K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp.20021

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K962970, 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), the FDA summary (predicates and indications), 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K942058Spacelabs Medical Ecg Module (Model 90492)
Summary page 1
…edicate The Spacel.abs Medical 12 Lead Diagnostic ECG Device(s) Analysis Option is a modification to the existing SpacelLabs Medical 12 Lead ECG Module, as described in K942058. As a result of a business relationship between Mortara Instruments and Spacelabs Medical, the diagnostic ECG algorithm used in t…
Spacelabs Medical, Inc.1995—
*K933143Model Eli 300 Electrocardiograph
Summary page 1
…Spacelabs Medical, the diagnostic ECG algorithm used in the Diagnostic ECG Analysis Option are identical to those found in the Mortara Instrument ELI300, as described in K933143. 4. The Spacelabs Medical 12-Lead Diagnostic ECG Analysis Option is a software- only option added to the 90492 module software,…
Mortara Instrument, Inc.1994—

Also cleared against K942058: 2 other devices →

What descends from it? (150)

See all 150

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

NumberDeviceApplicantDecidedDescendants
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K972502 (Spacelabs Medical, Inc., 1998) has gone furthest, with 149 descendants of its own.
  • 2 other devices also cite its predicate K942058.

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—

What is it indicated for?

The Spacelabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the Spacelabs Medical Model 90492 ECG module.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K942058

2 other devices cite the same predicate.

  • K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 19983 recalls
  • K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997

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
  • K112962Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc. · 20117 recalls
  • 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

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K962970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962970: Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962970

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026