510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Spacelabs Alpha PC Patient Computer

K842616510(k) TraditionalCleared Oct 18, 1984105-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, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 18, 1984 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 165 later devices descend from it. It has been recalled 2 times.

Decided
Oct 18, 1984
Review
105 days
Class
Class II
Product code
DSI
Recalls
2
Predicates
0

165 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared2008: 8 descendants cleared2003: 2 descendants cleared2012: 10 descendants cleared2010: 14 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2002: 2 descendants cleared2000: 1 descendant cleared2016: 8 descendants cleared2007: 4 descendants cleared2009: 11 descendants cleared2006: 8 descendants cleared2017: 11 descendants cleared2011: 6 descendants cleared2025: 3 descendants cleared2013: 9 descendants cleared2014: 7 descendants cleared2005: 2 descendants cleared2004: 2 descendants cleared2026: 4 descendants cleared2018: 9 descendants cleared2015: 8 descendants cleared2020: 3 descendants cleared2019: 7 descendants cleared2021: 5 descendants cleared2024: 5 descendants cleared2022: 7 descendants cleared2023: 5 descendants cleared19801990200020102020
  1. This deviceK842616 Spacelabs Alpha PC Patient ComputerSpacelabs, Inc. · 1984
  2. Descendant · cites it directly · 124 of its ownK972282 Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  4. Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
  5. Descendant · 4 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  6. 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 165 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11999: 12000: 12001: 12002: 22003: 22004: 22005: 22006: 82007: 42008: 82009: 112010: 142011: 62012: 102013: 92014: 72015: 82016: 82017: 112018: 92019: 72020: 32021: 52022: 72023: 52024: 52025: 32026: 4
1996high 14 (2010) · low 0 (1998)2026

Most influential descendants

Showing 5 of 165 · See all
  • K972282Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 1997 · cites it directly124descendants
  • 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
0 (this device)K842616Spacelabs Alpha PC Patient ComputerSpacelabs, Inc.1984—
+1K972282Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc.19974
+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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910
200010
200110
200220
200320
200420
200520
200680
200740
200880
2009110
2010140
201160
2012100
201390
201470
201580
201680
2017110
201890
201970
202030
202150
202270
202350
202450
202530
202640
FIG. 1 — Lineage of K842616, 1984–2026Source: 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? (165)

See all 165

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

NumberDeviceApplicantDecidedDescendants
K972282Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc.1997124
K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.199639

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 27, 2012Class IIZ-2382-2012Mixed-up of materials/componentsThere is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Sep 16, 2005Not classifiedZ-0063-06OtherECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972282 (Spacelabs Medical, Inc., 1997) has gone furthest, with 124 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, Inc.

46 FDA decisions under this applicant name. See the company

  • K954962Spacelabs Medical Multigas AnalyzerSpacelabs, Inc. · 1996
  • K951605Spacelabs Medical Casemaster Information Management SystemSpacelabs, Inc. · 1995
  • K950779Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
  • K941165Comet Capnograph ModuleSpacelabs, Inc. · 1994
  • K923788Space Labs Model 90560Spacelabs, Inc. · 1993

Recent decisions in DSI

The DSI category page

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  • 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/K842616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K842616: Spacelabs Alpha PC Patient Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842616

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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