510(k) · Cleared
Recalled · Class II · 2016VC150 Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innokas Yhtyma · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 30, 2014 as substantially equivalent to K102426 (Ge Medical Systems Information Technologies, 2010) and 3 other predicates after a 318-day review. Its family tree reaches back 14 generations to 1997. 3 of the 108 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 30, 2014
- Review
- 318 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 14 generations to K962603 (1997). 104 ancestors in all, the oldest K853990 (1985). 3 later devices descend from it, 2 citing it directly. 3 of the 108 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK133810 VC150 Vital Signs MonitorInnokas Yhtyma · 2014
- Descendant · cites it directly · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233810 Portrait VSMGe Medical Systems Information Technologies, Inc. · 2024 · Recalled
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 9 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 8 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 6 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 5 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 4 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK133810 VC150 Vital Signs MonitorInnokas Yhtyma · 2014
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · cites it directly2descendants
- K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc. · 2025 · 2 generations on0descendants
- K233810Portrait VSMGe Medical Systems Information Technologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −9 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −8 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −7 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −5 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −4 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −3 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −2 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −1 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | — |
| 0 (this device) | K133810 | VC150 Vital Signs Monitor | Innokas Yhtyma | 2014 | — |
| +1 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +2 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | — |
| +1 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 8 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 1 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 1 |
| 2003 | 4 | 0 |
| 2004 | 5 | 1 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
3 devices in this family have 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K102426 | Carescape Model V100 Vital Signs MonitorSummary page 5…Name: Physiological or Vital Signs Monitor; Patient Monitor Classification Names: 21 CFR 870.2300 Product Code: MWI Predicate K102426 CARESCAPE V100 Vital Signs Monitor Device(s): K101680 Welch Allyn Spot Ultra Vital Signs and Welch Allyn… | 2010 |
| * | K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesSummary page 5…r Classification Names: 21 CFR 870.2300 Product Code: MWI Predicate K102426 CARESCAPE V100 Vital Signs Monitor Device(s): K101680 Welch Allyn Spot Ultra Vital Signs and Welch Allyn Spot Vital Signs LXi… | 2010 |
| * | K110028 | Masimo Radical Y Pulse CO-OximeterSummary page 6…Fax +358 8 5623151 www.innokasmedical.fi K110028 Masimo Rainbow SET® Radical 7 Pulse CO‐Oximeter and Accessories K121806 Bedside Respiratory Patie… | 2011 |
| * | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Summary page 6…www.innokasmedical.fi K110028 Masimo Rainbow SET® Radical 7 Pulse CO‐Oximeter and Accessories K121806 Bedside Respiratory Patient Monitoring System Device The VC150 is a portable vital signs monitor for use in hospitals D… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2016 | Class II | Z-2604-2016 | Software design | A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. |
| Oct 22, 2015 | Class II | Z-0264-2016 | Software design | Monitor may shut down unintentionally without restarting. |
| Dec 3, 2014 | Class II | Z-1022-2015 | Software design | If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms. |
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.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 20 of the 104 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K213490 (Ge Medical Systems Information Technologies, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K102426.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The VC150 is intended to monitor a single patient’s vital signs at the site of care or during intra-hospital transport. The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen…
Read the full statement (423 words)
The VC150 is intended to monitor a single patient’s vital signs at the site of care or during intra-hospital transport.
The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.
The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of:
• functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients,
• carboxyhemoglobin saturation (SpCO) for adult and pediatric patients,
• methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients,
• total hemoglobin concentration (SpHb) for adult and pediatric patients, and/or
• respiratory rate (RRa) for adult and pediatric patients.
The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.
The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions.
The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric patients. The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages.
A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.
The portable device is designed for use in hospitals and hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings.
“Portable” refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133810: VC150 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133810
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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