# K970445: Vitalmax 4000 Configured/Vitalmax 4000 Modular/Vitalmax 4100/Minipack 3100/3000/Vitalmax 800+/Minipack 300

- Pathway: 510(k) (Traditional)
- Applicant: Pace Tech Medical Monitors, Inc.
- Decided: Jan 30, 1998 after 359 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Vitalmax 4000 Configured / Modular The Vitalmax 4000 is intended for use in the hospital/clinical environment to measure and monitor the fellowing parameters: ECG waveform NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) Blood oxygen saturation (SpO2 or Pulse oximetry) SpO2 waveform Pulse (SpO2 and NIBP) signal strength Pulse (SpO2 and NIBP) or heart (ECG) rate Temperature End-tidal Co2 concentration (Et Co2) Co2 waveform Minimum inspired Co2 concentration (inCo2) Respiration rate Additional options offered are: • Built-in printer with two channels of annotated waveform or text form of vital signs Thoracic impedance respiration Invasive pressure waveforms: systolic, diastolic, and mean values (IP, IP2) Second temperature channel and A temp Analog output 4000 configured monitor is available in various models which offer the options of Co2, thoracic impedance respiration, printer, and invasive pressures. The vitalmax 4000 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging). Vitalmax 4100 The Vitalmax 4100 CN is intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) Blood oxygen saturation (SpO2 or Pulse oximetry) SpO2 waveform Pulse (SpO2 and NIBP) signal strength Pulse (SpO2 and NIBB) or heart (ECG) rate Temperature End-tidal Co2 concentration (Et Co2) Co2 waveform Minimum inspired Co2 concentration (inCo2) Respiration rate Nitrous oxide concentration (N20) The Vitaimax 4100 G and Vitalmax 4100 A include these additional parameters: • End-tidal expired Halothane, Enflurane, or Isoflurane agent gas concentration (etHAL, etENF, etISO) • Inspired Halothane, Enflurane, or Isoflurane agent gas concentration (inHAL, inENF, inISO) • Fractional inspired oxygen in gas concentration (Fio2 or %02) Additional options offered for both models are: • Thoracic impedance respiration • Invasive pressure waveform, systolic, diastolic and mean values (IP1, IP2) Second temperature channel and teperature difference [A temp] Built-in strip chart recorder Sevoflurane, and Desflurane (etSev, inSev, etDes, inDes) Analog Output The Vitalmax 4100 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging). Minipack 3000/3100 The Minipack 3000 and Minipack 3100 are intended for use in the hospital/clinical environment to measure and monitor the following parameters: • ECG waveform NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) Blood oxygen saturation (SpO2 or Pulse oximetry) SpO2 waveform Pulse (SpO2 and NIBP) signal strength Pulse (SpO2 and NIBP) or heart (ECG) rate Temperature End-tidal Co2 concentration (Et Co2) Co2 waveform Minimum inspired Co2 concentration (inCo2) Respiration rate Additional options offered are: Built-in printer with two channels of annotated waveform or text form of vital signs Thoracic impedance respiration Invasive pressure waveforms: systolic, diastolic, and mean values (IP1, IP2) Second temperature channel and A temp Analog output The vitalmax 3000 and Vitalmax 3100 are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging). Minipack 300/ Vitalmax 800 PLUS The Minipack 300 and Vitalmax 800 PLUS are intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) Blood oxygen saturation (SpO2 or Puise oximetry) SpO2 waveform Pulse (SpO2 or NIBP) signal strength Pulse (SpO2 and NIBP) or heart (ECG) rate Temperature End-tidal Co2 concentration (Et Co2) Co2 waveform Minimum inspired Co2 concentration (inCo2) Respiration rate Additional options offered are: Thoracic impedance respiration Add-on 27 ccolumn thermal printer (Minipack 300 Series) Built-in printer with two channels of annotated waveform (Vitaimax 800 PLUS) Analog output The Minipack 300 and Vitalmax 800 PLUS are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging).

Source page: https://510kreport.com/device/K970445
Methodology: https://510kreport.com/methodology