510(k) Report

510(k) · Cleared

Recalled · 2008

Model 90478 & 90479 Telemetry Rec. Module&Housing

K925510510(k) TraditionalCleared Oct 27, 1994727-day reviewClass II21 CFR 870.1025Recalls 2

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 Oct 27, 1994 after a 727-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 155 later devices descend from it. It has been recalled 2 times.

Decided
Oct 27, 1994
Review
727 days
Class
Class II
Product code
DSI
Recalls
2
Predicates
0

155 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2017: 10 descendants cleared1999: 1 descendant cleared1997: 1 descendant cleared2014: 10 descendants cleared2004: 3 descendants cleared2007: 5 descendants cleared1998: 1 descendant cleared2012: 6 descendants cleared2008: 7 descendants cleared2015: 10 descendants cleared2002: 1 descendant cleared2005: 3 descendants cleared2006: 6 descendants cleared2000: 1 descendant cleared2010: 10 descendants cleared2003: 1 descendant cleared2009: 10 descendants cleared2011: 5 descendants cleared2016: 7 descendants cleared2019: 7 descendants cleared2013: 7 descendants cleared2018: 8 descendants cleared2020: 2 descendants cleared2021: 5 descendants cleared2024: 6 descendants cleared2023: 7 descendants cleared2022: 7 descendants cleared2026: 5 descendants cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK925510 Model 90478 & 90479 Telemetry Rec. Module&HousingSpacelabs Medical, Inc. · 1994
  2. Descendant · cites it directly · 150 of its ownK952912 Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997
  3. Descendant · 2 generations on · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
  4. Descendant · 3 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  5. Descendant · 4 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
  6. Descendant · 5 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12000: 12002: 12003: 12004: 32005: 32006: 62007: 52008: 72009: 102010: 102011: 52012: 62013: 72014: 102015: 102016: 72017: 102018: 82019: 72020: 22021: 52022: 72023: 72024: 62025: 32026: 5
1997high 10 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 155 · See all
  • K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997 · cites it directly150descendants
  • K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · 2 generations on149descendants
  • K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 3 generations on119descendants
  • K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 4 generations on88descendants
  • K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 5 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925510Model 90478 & 90479 Telemetry Rec. Module&HousingSpacelabs Medical, Inc.1994—
+1K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997—
+2K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.19983
+3K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001
+4K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2004—
+5K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200010
200210
200310
200430
200530
200660
200750
200870
2009100
2010100
201150
201260
201370
2014100
2015100
201670
2017100
201880
201970
202020
202150
202270
202370
202460
202530
202650
FIG. 1 — Lineage of K925510, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (155)

See all 155

5 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
K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926
K141156Spacelabs Healthcare Telemetry ReceiverSpacelabs Healthcare20141
K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041
K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 18, 2008Not classifiedZ-1652-2008Software designTelemetry Modules are failing to alarm for low heart rate and asystole.
May 5, 2006Not classifiedZ-1202-06OtherPotential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

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
  • 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
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https://510kreport.com/device/K925510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925510

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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