510(k) · Cleared
ClearedWelch Allyn 1500 Patient Monitor
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 Nov 12, 2010 as substantially equivalent to K053207 (Schiller AG, 2006) and 4 other predicates after a 156-day review. Its family tree reaches back 10 generations to 1997. 1 of the 82 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Nov 12, 2010
- Review
- 156 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962603 (1997). 77 ancestors in all, the oldest K842616 (1984). 4 later devices descend from it, 1 citing it directly. 1 of the 82 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 1 generation backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- This deviceK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · cites it directly · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK201746 Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · Recalled
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 5 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 4 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 1 generation backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- This deviceK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
Class I recalls in this family
- K970209 Capnocheck Plus5 generations back · 1997
Most influential descendants
Showing 4 of 4 · See all- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · cites it directly3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 2 generations on2descendants
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 3 generations on1descendant
- K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −5 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −4 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −3 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −2 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −1 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| 0 (this device) | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +1 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +2 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +3 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
| +4 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 1 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K053207 | Argus, Model LCMSummary page 1…- 12-lead Rest-ECG Analysis The 12-lead Rest-ECG Analysis algorithm used in the 1500 Patient Monitor has been FDA- cleared in the SCHILLER ARGUS [CM K053207). Parameters - Temperature The Patient Temperature parameter circuitry and algorithm used in theWelch Allyn 1… | 2006 |
| * | K063814 | BP-200 PlusSummary page 1…e The Not Invasive Blood Pressure parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER BP-200plus (K063814). Parameters -Invasive Blood Pressure The Invasive Blood Pressure parameter circuitry and algorithm used in t… | 2007 |
| * | K051352 | Oximax NPB-40 Handheld Pulse OximeterSummary page 2…pOZ) The SpO2 parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA- cleared in the Nellcor Oximax NPB-40 Pulse Oximeter (K051352). Parameters - ECG Arrhythmia / ST-segment Analysis The Mortara ECG Arrhythmia and ST-segment analysis algo… | 2005 |
| * | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXSummary page 5…e medical device standards and equivalent to the SCHILLER ARGUS LCMKOS32O7; SP02 Module Nelcor K051352; C02 Module Oridien K072295; ECG Library Mortara K020550; NIBPNodule SCHILLER K063814 all parameters currently on the market. Baar (Switzerland) 2 8 th May 2010… | 2002 |
| * | K072295 | Capnostream 20 with A2 Adaptive Averaging SoftwareSummary page 5…e, comply with the appropriate medical device standards and equivalent to the SCHILLER ARGUS LCMKOS32O7; SP02 Module Nelcor K051352; C02 Module Oridien K072295; ECG Library Mortara K020550; NIBPNodule SCHILLER K063814 all parameters currently on the market. Baar (Switzerland)… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133973 | Tempus Pro with Enhanced Features | 2014 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 77 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133973 (Remote Diagnostic Technologies, Ltd., 2014) has gone furthest, with 3 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. 2010, 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 Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates; children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring. Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery. The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of…
Read the full statement (234 words)
The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for
neonates; children, adult and paediatric use. It has a LCD screen for comprehensive
vital data monitoring.
Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor
also provides full vital data monitoring during transport with the built-in battery.
The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the
monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure
(NIBP), invasive blood pressure (11BP), temperature and respiration of a patient.
>The device is intended to be used by qualified doctors or trained medical
personnel.
>The device is not suitable for transport.
>There is no danger for patients with pacemaker.
>The device is intended for the monitoring of one patient at a time.
> The device is not designed for sterile use nor is it designed for outdoor use.
- Do not use this monitor in areas where there is any danger of explosion or in the
presence of flammable gases.
> The device is classified CF. It is defibrillation protected when the original
accessories are used. However, as a safety precaution when possible, remove the
electrodes before defibrillation.
> This product is not designed for direct cardiac application.
> The arrhythmia module is not intended for use with neonatal patients.
> The ST-analysis module is not intended for use with neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101619: Welch Allyn 1500 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101619
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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