# K062098: Spectrum Monitor, Model 0998-00-1000-Xxxxx

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Feb 5, 2007 after 196 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933143 (1994). 33 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031849: Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx, Datascope Corp. (2003) Summary page 1.
- K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options, GE Healthcare (2006) Summary page 1.

## Most influential descendants
- K102004: Endeavour Monitoring System (2010), 3 descendants of its own
- K132229: Omni Patent Monitors (2014), 2 descendants of its own
- K132026: V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 (2013), 2 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K153079: Axeo 3 Patient Monitor (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K062098
Methodology: https://510kreport.com/methodology