510(k) · Cleared
ClearedSpacelabs Medical Integrated Multi-Parameter Module
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 Apr 2, 1997 as substantially equivalent to K945429 (Spacelabs Medical, Inc., 1995) and 6 other predicates after a 646-day review. Its family tree reaches back 1 generation to 1989. 150 later devices descend from it.
- Decided
- Apr 2, 1997
- Review
- 646 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 1 generation to K882609 (1989). 7 ancestors in all. 150 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK882609 Models M1175A & M1176A Component Monitoring SystemWaltham Div. Hewlett Packard · 1989
- This deviceK952912 Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997
- Descendant · cites it directly · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 4 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882609 | Models M1175A & M1176A Component Monitoring System | Waltham Div. Hewlett Packard | 1989 | — |
| 0 (this device) | K952912 | Spacelabs Medical Integrated Multi-Parameter Module | Spacelabs Medical, Inc. | 1997 | — |
| +1 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| +2 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| +3 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +4 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +2 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (9)
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 |
|---|---|---|---|
| * | K945429 | Spacelabs Medical Expansion Module (Model 90352) Cleared while this submission was under review Summary page 1…eter (No. 74DQA) which has been classified as a Class Il device, in accordance to 21 CFR 870.2700 a. Spacelabs Medical 90352 PC Scout Expansion Housing, as described in K945429. b. Spacelabs Medical 90492 ECG Module, as described in K942058,; C. Spacelabs Medical 90478 Telemetry Receiver, as described i… | 1995 |
| * | K942058 | Spacelabs Medical Ecg Module (Model 90492)Summary page 1…in accordance to 21 CFR 870.2700 a. Spacelabs Medical 90352 PC Scout Expansion Housing, as described in K945429. b. Spacelabs Medical 90492 ECG Module, as described in K942058,; C. Spacelabs Medical 90478 Telemetry Receiver, as described in K922510; d. Spacel.abs Medical 90553 NIBP Monitor, as describe… | 1995 |
| * | K925510 | Model 90478 & 90479 Telemetry Rec. Module&Housing Our OCR of the scanned summary read K922510, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spacelabs Medical 90478 Telemetry Receiver”. | 1994 |
| * | K941167 | Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)Summary page 1…ECG Module, as described in K942058,; C. Spacelabs Medical 90478 Telemetry Receiver, as described in K922510; d. Spacel.abs Medical 90553 NIBP Monitor, as described in K941167; e. Nellcor N-180 pulse oximeter, as described in K913695; f. Spacel abs Medical 90489 Sp0O2 Module, as described in K301209;… | 1994 |
| * | K913695 | Nellcor (R) N-180 Pulse OximeterSummary page 1…90478 Telemetry Receiver, as described in K922510; d. Spacel.abs Medical 90553 NIBP Monitor, as described in K941167; e. Nellcor N-180 pulse oximeter, as described in K913695; f. Spacel abs Medical 90489 Sp0O2 Module, as described in K301209; g. Hewlett Packard CMS and M1175A, as described in K882609… | 1991 |
| Kept off the family tree | K901209 | FDA’s K901209 is Model 90489 Pulse Oximeter Module Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
| * | K882609 | Models M1175A & M1176A Component Monitoring SystemSummary page 1…or N-180 pulse oximeter, as described in K913695; f. Spacel abs Medical 90489 Sp0O2 Module, as described in K301209; g. Hewlett Packard CMS and M1175A, as described in K882609 and K900032; and h. Marquette Tramscope System, as described in K300598. The Spacelabs Medical Integrated Multi-… | 1989 |
| * | K900032 | Model M1175A/M1176A with ST Segment MonitoringSummary page 1…se oximeter, as described in K913695; f. Spacel abs Medical 90489 Sp0O2 Module, as described in K301209; g. Hewlett Packard CMS and M1175A, as described in K882609 and K900032; and h. Marquette Tramscope System, as described in K300598. The Spacelabs Medical Integrated Multi-Parameter Mo… | 1990 |
| Kept off the family tree | K900598 | FDA’s K900598 is Tramscope System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
What descends from it? (150)
See all 1501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | 1998 | 149 |
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?
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?
The Spacelabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a Spacelabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are…
Read the full statement (123 words)
The Spacelabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a Spacelabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected.
The Spacelabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.
The Spacelabs Medical Integrated Multi-Parameter Module is intended for use on both adult and neonatal patient populations in all clinical settings. The Spacelabs Medical Integrated Multi-Parameter Module is not intended for home use.
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/K952912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952912: Spacelabs Medical Integrated Multi-Parameter Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952912
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