510(k) · Cleared
Recalled · Class II · 2025Argus PB-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 6, 2023 as substantially equivalent to K012226 (Schiller AG, 2002) after a 451-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Jul 6, 2023
- Review
- 451 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970879 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K012226 | Monitoring System,Model Argus PB-1000Summary page 5…t code MHX Regulation Number 21 CFR 870.1025 2.1. Predicate Device Device Name ARGUS PB-1000 System 510(k) number K012226 Device Class II Product code MHX Regulation Number 21 CFR 870.1025… | 2002 |
| † | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | 2020 |
| † | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2025 | Class II | Z-2672-2025 | Nonconforming Material/Component | Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 21.2 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K012226.
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. 2023, 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 ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient. Indicated for the following applications: ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient’s ECG rhythm, heart rate…
Read the full statement (316 words)
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient.
Indicated for the following applications:
ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient’s ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System).
Respiration rate and apnea monitoring is indicated for pneumatic issues.
IBP - Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient’s condition or response to therapy. It may also be used to aid in medical diagnosis.
NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure.
SpO2 - These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. This monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused.
CO2 - The CO2 measurement is used to detect trends in the level of inspired or expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Respiration rate and apnea monitoring is indicated for pneumatic issues.
Cardiac Output (CO) - Cardiac Output measurement is indicated for use in patients who require a non-continuous measurement of the stroke volume and l/min volume of the heart.
Temperature - Temperature measurement is indicated in any patient that has a risk of high or low temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221056: Argus PB-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221056
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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