510(k) · Cleared
ClearedVitalsens, Aingeal, V-Pod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelesens Limited · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 20, 2011 as substantially equivalent to K071805 (Datascope Corp., 2007) and 3 other predicates after a 137-day review. Its family tree reaches back 8 generations to 1997. 4 later devices descend from it.
- Decided
- May 20, 2011
- Review
- 137 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962603 (1997). 43 ancestors in all, the oldest K854030 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 1 generation backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- This deviceK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · cites it directly · 1 of its ownK132407 Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK153275 Aingeal Activity SystemIntelesens, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK151835 Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK151027 zensor systemIntelesens Limited · 2015
Most influential descendants
Showing 4 of 4 · See all- K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014 · cites it directly1descendant
- K153275Aingeal Activity SystemIntelesens, Ltd. · 2016 · cites it directly0descendants
- K151835Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016 · 2 generations on0descendants
- K151027zensor systemIntelesens Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −1 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| 0 (this device) | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +1 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | — |
| +1 | K153275 | Aingeal Activity System | Intelesens, Ltd. | 2016 | — |
| +2 | K151835 | Vital Signs Patch System | Lifewatch Technologies, Ltd. | 2016 | — |
| +1 | K151027 | zensor system | Intelesens Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXSummary page 1…ng ST-segment measurement and alarm) DSI Predicate Device: K(071805 Datascope NetGuard Automated Clinician Alert… | 2007 |
| * | K093976 | Raisin Personal MonitorSummary page 1…Datascope NetGuard Automated Clinician Alert System K(093976 Proteus Biomedical Raisin Personal Monitor… | 2010 |
| * | K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Summary page 1…Proteus Biomedical Raisin Personal Monitor K083 185 CADI Scientific CADI SmartSense Wireless Temp… | 2009 |
| * | K033378 | Vital Signs Monitor, Propaq LTSummary page 1…CADI Scientific CADI SmartSense Wireless Temperature Monitor K033378 Welch Allyn Vital Signs Monitor Propaq Lt De… | 2004 |
What descends from it? (4)
3 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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 8 of the 43 ancestors have a recall of any class.
- Of its descendants, K132407 (Lifewatch Technologies, Ltd., 2014) has gone furthest, with 1 descendant 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. 2011, 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 intelesens Vital Signs Monitor Aingeal (VS200) is used to mnonitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is…
Read the full statement (177 words)
The intelesens Vital Signs Monitor Aingeal (VS200) is used to mnonitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short termi periods only.
The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useflul.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmnia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmnia event.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110015: Vitalsens, Aingeal, V-Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110015
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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