# K031849: Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Sep 9, 2003 after 85 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933143 (1994). 28 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX, Datascope Corp. (2002) Summary page 1.
- K030431: Modification to Dash 3000/4000 Patient Monitor, Ge Medical Systems Information Technologies (2003)

## Most influential descendants
- K062098: Spectrum Monitor, Model 0998-00-1000-Xxxxx (2007), 7 descendants of its own
- 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

## Recalls of this device
- Sep 7, 2005 · Not classified · Z-0176-06: Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

## 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 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.

Source page: https://510kreport.com/device/K031849
Methodology: https://510kreport.com/methodology