510(k) · Cleared
Recalled · 2008Spacelabs Medical Integrated Multiparameter Module 90496
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 May 28, 1998 as substantially equivalent to K952912 (Spacelabs Medical, Inc., 1997) and 4 other predicates after a 329-day review. Its family tree reaches back 2 generations to 1994. 149 later devices descend from it. It has been recalled 3 times.
- Decided
- May 28, 1998
- Review
- 329 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 2 generations to K933143 (1994). 11 ancestors in all, the oldest K882609 (1989). 149 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 1 generation backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- This deviceK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998
- 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 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · 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 |
|---|---|---|---|---|---|
| −2 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −1 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| 0 (this device) | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | — |
| +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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952912 | Spacelabs Medical Integrated Multi-Parameter ModuleSummary page 2…the Integrated Mulliparameter Module 90496 is substantially equivalent to 3 combination ot the Spacelabs Medical Integrated Muliparameter Module 90470 (510[k] reference K952912) far monitoring of electrocardiographic signals. respiralion, noninvasive pressure measurement and pulse oximetry oxygen saturati… | 1997 |
| * | K945429 | Spacelabs Medical Expansion Module (Model 90352)Summary page 2…iralion, noninvasive pressure measurement and pulse oximetry oxygen saturation (SpO2). Spacelabs Medical Integrated Multiparameler Expansion Housing Module 90352 (510fk] K945429) for monitoring of temperature and invasive blood pressure measurement, electrocardiographic activity and respiration; Spacela… | 1995 |
| * | K942058 | Spacelabs Medical Ecg Module (Model 90492)Summary page 2…temperature and invasive blood pressure measurement, electrocardiographic activity and respiration; Spacelabs Medical 12-Lead ECG and ST Segment Moduie 90492 (510(k]s K942058 and K962970) for 12-lead electrocardiogram monitoring: and the Baxter Edwards Critical Care Division Explorer Cardiac Ouiput Comp… | 1995 |
| * | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSummary page 2…and invasive blood pressure measurement, electrocardiographic activity and respiration; Spacelabs Medical 12-Lead ECG and ST Segment Moduie 90492 (510(k]s K942058 and K962970) for 12-lead electrocardiogram monitoring: and the Baxter Edwards Critical Care Division Explorer Cardiac Ouiput Computer (510[k]… | 1997 |
| * | K896920 | Sidewinder 40CC DL Intra-Aortic Balloon CatheterSummary page 2…duie 90492 (510(k]s K942058 and K962970) for 12-lead electrocardiogram monitoring: and the Baxter Edwards Critical Care Division Explorer Cardiac Ouiput Computer (510[k] K896920) tor monitoring cardiac autput. The Integrated Multiparameter Module 90496 is a slim, lightweight singular modular unit that. wh… | 1990 |
What descends from it? (149)
See all 1496 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | 2000 | 119 |
| K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | 2002 | 75 |
| K983996 | Spacelabs Medical Ultraview Digital Telemtry System | 1999 | 26 |
| K050175 | Spacelabs Medical Multiparameter Module 91496 | 2005 | 2 |
| K050605 | Spacelabs Medical Multiparameter Module 91496 | 2005 | 1 |
| K052544 | Pulse Oximeter Adapter Cables | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2008 | Not classified | Z-2343-2008 | Process control | Potential for module to fail to obtain a NIBP reading on hypertension patients. |
| Jul 22, 2008 | Not classified | Z-2342-2008 | Process control | Potential for module to fail to obtain a NIBP reading on hypertension patients. |
| Jul 2, 2008 | Not classified | Z-2314-2008 | Nonconforming Material/Component | Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K993531 (Datascope Corp., 2000) has gone furthest, with 119 descendants of its own.
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?
Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (Sp02) readings. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency as directed by physician. In conjunction with…
Read the full statement (221 words)
Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (Sp02) readings.
Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream.
Frequency as directed by physician.
In conjunction with clinical findings, a screening and diagnostic tool for use in:
assessing electrical activity - of the -heart in order - to- detect: abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation, as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations;
monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apneg;
continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure;
episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure;
continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature;
monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and
noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.
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/K972502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972502: Spacelabs Medical Integrated Multiparameter Module 90496.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972502
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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