510(k) · Cleared
Recalled · 2005Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 9, 2003 as substantially equivalent to K020550 (Datascope Corp., 2002) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933143 (1994). 28 ancestors in all, the oldest K842616 (1984). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 3 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 2 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 1 generation backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- This deviceK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003
- Descendant · cites it directly · 7 of its ownK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- Descendant · 2 generations on · 3 of its ownK102004 Endeavour Monitoring SystemMindray DS USA, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK132229 Omni Patent MonitorsInfinium Medical · 2014
- Descendant · 3 generations on · 2 of its ownK132026 V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007 · cites it directly7descendants
- K102004Endeavour Monitoring SystemMindray DS USA, Inc. · 2010 · 2 generations on3descendants
- K132229Omni Patent MonitorsInfinium Medical · 2014 · 2 generations on2descendants
- K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013 · 3 generations on2descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −4 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −3 | 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 |
| −1 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| 0 (this device) | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | — |
| +1 | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| +2 | K102004 | Endeavour Monitoring System | Mindray DS USA, Inc. | 2010 | 3 |
| +2 | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
| +3 | K132026 | V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 | Mindray DS USA, Inc. | 2013 | 1 |
| +4 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXSummary page 1…of the Datascope Corp. Passport 2@ Vital Signs Monitor with View 12 ECG Analysis Module, previously cleared by FDA under K020550. There have been no significant changes to the Passport 2@ Vital Signs Monitor with View 12" ECG Analysis… | 2002 |
| * | K030431 | Modification to Dash 3000/4000 Patient Monitor | 2003 |
What descends from it? (9)
2 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 7, 2005 | Not classified | Z-0176-06 | Other | Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 28 ancestors have a recall of any class.
- Of its descendants, K062098 (Datascope Corp., 2007) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K020550.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Spectrum monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters: ECG waveform derived from 3,5 or 12 lead measurements Heart Rate derived from selected sources (ECG, SpO,, IBP, NLBP) Pulse Oximetry (SpO, ) ST Segment Analysis derived from 3,5 or 12 ECG lead measurements…
Read the full statement (199 words)
The Spectrum monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters:
ECG waveform derived from 3,5 or 12 lead measurements
Heart Rate derived from selected sources (ECG, SpO,, IBP, NLBP)
Pulse Oximetry (SpO, )
ST Segment Analysis derived from 3,5 or 12 ECG lead measurements
Arrhythrma Detection derived from 3,5 of 12 ECG lead measurements
Interpretation of Resting 12 lead ECG
Non Invasive Blood Pressure (NIBP)
Invasive Blood Pressure (IBP) - up to four (4)channels
Cardiac Output
Respiration Ratel waveform derived from ECG or CO,
C02, inspired and end tidal microstreaml waveform
Temperature - up to two (2) channels
Hemodynamic Calculations
IV Drug Calculations
The target populations are adult, pediatric and neonate with the exception of the:
Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, for which the target populations are adult and pediatric only, and
Interpretation of Resting 12 Lead ECG and IV Drug Calculations for which the target population is adult only.
The Spectrum monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations and Gas Module products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031849: Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031849
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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