510(k) · Cleared
ClearedMonitoring System,Model Argus PB-1000
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 Apr 8, 2002 as substantially equivalent to K970879 (Schiller America, Inc., 1997) after a 266-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.
- Decided
- Apr 8, 2002
- Review
- 266 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970879 (1997). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK970879 Cardiovit CS-200Schiller America, Inc. · 1997
- This deviceK012226 Monitoring System,Model Argus PB-1000Schiller AG · 2002
- Descendant · cites it directly · 5 of its ownK053207 Argus, Model LCMSchiller AG · 2006
- Descendant · 2 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 3 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K053207Argus, Model LCMSchiller AG · 2006 · cites it directly5descendants
- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · 2 generations on4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 3 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 4 generations on2descendants
- K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970879 | Cardiovit CS-200 | Schiller America, Inc. | 1997 | — |
| 0 (this device) | K012226 | Monitoring System,Model Argus PB-1000 | Schiller AG | 2002 | — |
| +1 | K053207 | Argus, Model LCM | Schiller AG | 2006 | — |
| +2 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +3 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +4 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +1 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
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 |
|---|---|---|---|
| * | K970879 | Cardiovit CS-200Summary page 1…rgus PB-1000 System 2. Common Name: Monitoring System A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: Cardiovit CS — 200 K 970879 A4 Intended Use The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as: ECG: Heartrate, Asystol… | 1997 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K053207 (Schiller AG, 2006) has gone furthest, with 5 descendants of its own.
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?
The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as: ECG: Heartrate, Asystolic Time, Respiration Rate invasive Blood Pressure: systolic, distolic and mean pressure Temperature: temperature and AT Non Invasive Blood Pressure: systolic, distolic and mean pressure CO,, etCO, and COsins SpOa: SpO; and pulse rate on humans and for the evaluation of Reéting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm…
Read the full statement (199 words)
The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as:
ECG: Heartrate, Asystolic Time, Respiration Rate
invasive Blood Pressure: systolic, distolic and mean pressure
Temperature: temperature and AT
Non Invasive Blood Pressure: systolic, distolic and mean pressure
CO,, etCO, and COsins
SpOa: SpO; and pulse rate
on humans and for the evaluation of Reéting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments.
The system comprises the Parameter Box PB-1000 and the Visualisation Unit ARGUS PRO. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.
The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.
The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012226: Monitoring System,Model Argus PB-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012226
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026