510(k) · Cleared
ClearedArgus, Model LCM
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 May 19, 2006 as substantially equivalent to K012226 (Schiller AG, 2002) and 1 other predicate after a 184-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- May 19, 2006
- Review
- 184 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970879 (1997). 4 ancestors in all, the oldest K953396 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970879 Cardiovit CS-200Schiller America, Inc. · 1997
- 1 generation backK012226 Monitoring System,Model Argus PB-1000Schiller AG · 2002
- This deviceK053207 Argus, Model LCMSchiller AG · 2006
- Descendant · cites it directly · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 2 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
- Descendant · 5 generations on · 0 of its ownK201746 Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · cites it directly4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 2 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 3 generations on2descendants
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 4 generations on1descendant
- K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970879 | Cardiovit CS-200 | Schiller America, Inc. | 1997 | — |
| −1 | K012226 | Monitoring System,Model Argus PB-1000 | Schiller AG | 2002 | — |
| 0 (this device) | K053207 | Argus, Model LCM | Schiller AG | 2006 | — |
| +1 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +2 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +3 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +4 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
| +5 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (2)
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 1…Monitoring System A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: ARGUS PB-1000 System K012226 Cardiovit AT-102 K031557 A4 Intended Use The Monitoring System ARGUS LCM is for the monitoring of vital… | 2002 |
| * | K031557 | Cardiovit at-102Summary page 1…Marketed Device Legally Marketed Device to which this submitted device is compared: ARGUS PB-1000 System K012226 Cardiovit AT-102 K031557 A4 Intended Use The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: - ECG: Heartrate, Res… | 2004 |
| † | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor… | 1999 |
| † | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | 2002 |
| † | K022084 | Atlas Monitor, Models 200,210,220 | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101619 | Welch Allyn 1500 Patient Monitor | 2010 | 4 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101619 (Schiller AG, 2010) has gone furthest, with 4 descendants of its own.
- 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.
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 LCM is for the monitoring of vital parameters such
as:
- ECG: Heartrate, Respiration Rate
- Invasive Blood Pressure: systolic, diastolic and mean pressure
- Temperature: temperature
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure
- CO2, etCO 2 and CO 2ins
- SPO2: SPO2 and pulse rate
There is alarm handling for all parameters except temperature.
The ARGUS LCM is powered via the normal mains connection 230V/1 1OV, and
using an internal battery and an external power input.
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 as stated in the FDA summary.
https://510kreport.com/device/K053207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053207: Argus, Model LCM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053207
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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