510(k) · Cleared
ClearedSpectrum Monitor, Model 0998-00-1000-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 Feb 5, 2007 as substantially equivalent to K031849 (Datascope Corp., 2003) and 1 other predicate after a 196-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it.
- Decided
- Feb 5, 2007
- Review
- 196 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933143 (1994). 33 ancestors in all, the oldest K842616 (1984). 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 5 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 4 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 3 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 2 generations backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- 1 generation backK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003 · Recalled
- This deviceK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- Descendant · cites it directly · 3 of its ownK102004 Endeavour Monitoring SystemMindray DS USA, Inc. · 2010 · Recalled
- Descendant · cites it directly · 2 of its ownK132229 Omni Patent MonitorsInfinium Medical · 2014
- Descendant · 2 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 · 3 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK153079 Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102004Endeavour Monitoring SystemMindray DS USA, Inc. · 2010 · cites it directly3descendants
- K132229Omni Patent MonitorsInfinium Medical · 2014 · cites it directly2descendants
- K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013 · 2 generations on2descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on1descendant
- K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −5 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −4 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −3 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −2 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| −1 | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | 1 |
| 0 (this device) | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| +1 | K102004 | Endeavour Monitoring System | Mindray DS USA, Inc. | 2010 | 3 |
| +1 | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
| +2 | K132026 | V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 | Mindray DS USA, Inc. | 2013 | 1 |
| +3 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | 2016 | — |
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 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-XxxxxSummary page 1…ter and rate alarm) 21 CER 870.2700- Oximeter 21 CFR 880.2910- Monitor, Temperature (with probe) Predicate Devices: K03 1849 Spectrum Monitor K05 1400 Datex Obmeda S/5Tm Anesthesia Monitor with L-ANE05 and L-ANE05A… | 2003 |
| * | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or…Summary page 1…870.2700- Oximeter 21 CFR 880.2910- Monitor, Temperature (with probe) Predicate Devices: K03 1849 Spectrum Monitor K05 1400 Datex Obmeda S/5Tm Anesthesia Monitor with L-ANE05 and L-ANE05A Software Device Description:… | 2006 |
| † | K040183 | BISX | 2004 |
What descends from it? (7)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 10 of the 33 ancestors have a recall of any class.
- Of its descendants, K102004 (Mindray DS USA, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K031849.
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. 2007, this device’s year, is highlighted.
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 Monitor 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, SPO2, IBP, NIBP) Pulse Oximetry (SPO2) ST Segment Analysis derived from 3, 5 orl2 ECG lead measurements…
Read the full statement (340 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 Monitor 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, SPO2, IBP, NIBP)
Pulse Oximetry (SPO2)
ST Segment Analysis derived from 3, 5 orl2 ECG lead measurements
Arrhythmia Detection derived from 3, 5 or 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 Rate/waveform derived from ECG or CO 2
GO 2, inspired and end tidal microstream/waveform
Temperature - up to two (2) channels
Hemodynamic Calculations
IV Drug Calculations
Bispectral Index (BIS)
The target populations are adult, pediatric and neonate with the exception of:
Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, Pulmonary Artery Wedge Pressure measurements, and
Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only.
Bispectral Index. The BISx is intended for use under direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population.
The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.
The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
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/K062098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062098: Spectrum Monitor, Model 0998-00-1000-Xxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062098
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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