510(k) · Cleared
ClearedVitalmax 4000 Configured/Vitalmax 4000 Modular/Vitalmax 4100/Minipack 3100/3000/Vitalmax 800+/Minipack 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pace Tech Medical Monitors, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 30, 1998 after a 359-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 30, 1998
- Review
- 359 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
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…
Read the full statement (600 words)
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).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970445: Vitalmax 4000 Configured/Vitalmax 4000 Modular/Vitalmax 4100/Minipack 3100/3000/Vitalmax 800+/Minipack 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026