510(k) · Cleared
Recalled · 2010Spacelabs Medical Pcis Patient Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Sep 25, 1997 as substantially equivalent to K842616 (Spacelabs, Inc., 1984) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1984. 124 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 25, 1997
- Review
- 99 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K842616 (1984). 2 ancestors in all. 124 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK842616 Spacelabs Alpha PC Patient ComputerSpacelabs, Inc. · 1984 · Recalled
- This deviceK972282 Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 1997
- Descendant · cites it directly · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- Descendant · 2 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 3 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- Descendant · cites it directly · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- Descendant · 4 generations on · 71 of its ownK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · cites it directly119descendants
- K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 2 generations on88descendants
- K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 3 generations on87descendants
- K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · cites it directly75descendants
- K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 4 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842616 | Spacelabs Alpha PC Patient Computer | Spacelabs, Inc. | 1984 | 2 |
| 0 (this device) | K972282 | Spacelabs Medical Pcis Patient Monitors | Spacelabs Medical, Inc. | 1997 | — |
| +1 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| +2 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +3 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +1 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| +4 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K842616 | Spacelabs Alpha PC Patient ComputerSummary page 1…bs Medical PCIS Patient Monitors are substantially equivalent to the PCIS patient monitors marketed by Spacelabs Medical, Inc. The PC1 Patient Monitor is marketed under K842616B. The Universal Clinical Workstation (UCW) is marketed under K832734. The PC Scout is a portable bedside monitor marketed under K… | 1984 |
| Kept off the family tree | K832734 | FDA’s K832734 is Kemtek 400 Ria Gamma Counter Our OCR of the scanned summary read K832734, FDA’s number for Kemtek 400 Ria Gamma Counter (Kemble Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Universal Clinical Workstation (UCW)”. Kept off the family tree. Summary page 1…PCIS patient monitors marketed by Spacelabs Medical, Inc. The PC1 Patient Monitor is marketed under K842616B. The Universal Clinical Workstation (UCW) is marketed under K832734. The PC Scout is a portable bedside monitor marketed under K930095. 4, Device Description Spacelabs Medical PCIS patient monito… | 1983 |
| * | K930095 | Spacelabs Medical Patient MonitorSummary page 1…Patient Monitor is marketed under K842616B. The Universal Clinical Workstation (UCW) is marketed under K832734. The PC Scout is a portable bedside monitor marketed under K930095. 4, Device Description Spacelabs Medical PCIS patient monitors (code name “Viper”) passively display data generated from Spacel… | 1993 |
What descends from it? (124)
See all 1243 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2010 | Not classified | Z-3036-2011 | Software design | Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem. |
| Nov 6, 2009 | Not classified | Z-0647-2010 | Component design/selection | Potential for monitor to shut down and not being able to power on again. |
| Nov 6, 2009 | Not classified | Z-0648-2010 | Component design/selection | Potential for monitor to shut down and not being able to power on again. |
| Nov 6, 2009 | Not classified | Z-0649-2010 | Component design/selection | Potential for monitor to shut down and not being able to power on again. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical. Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable…
Read the full statement (355 words)
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
General Spacelabs Medical PCIS Patient Monitor Intended Use Statement
Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network-based applications to open windows and display information on other networked monitors.
PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated: (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.
In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission.. Through this network, a patient’s data may be displayed at the bedside monitor, central station or a clinical information system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972282 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972282: Spacelabs Medical Pcis Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972282
Report an extraction error
Are you the manufacturer?
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