510(k) · Cleared
Cleared740 Select
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Medical Systems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 13, 2014 as substantially equivalent to K130411 (Cas Medical Systems, Inc., 2013) and 5 other predicates after a 114-day review. Its family tree reaches back 18 generations to 1994. 1 of the 147 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 13, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 18 generations to K941811 (1994). 145 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 147 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations between
- 3 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 2 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- 1 generation backK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
- This deviceK140430 740 SelectCas Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK150620 740 SelectCas Medical Systems, Inc. · 2015 · Recalled
Show all 18 generations
- Root · 18 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 17 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 16 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 15 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 14 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 13 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 12 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 11 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 10 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 9 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 8 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 7 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 6 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 5 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 4 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 3 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 2 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- 1 generation backK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
- This deviceK140430 740 SelectCas Medical Systems, Inc. · 2014
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K150620740 SelectCas Medical Systems, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −17 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −16 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −15 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −14 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −13 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −12 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −11 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −10 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −9 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −8 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −7 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −6 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −5 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −4 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| −3 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| −2 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| −1 | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | Masimo Corporation | 2012 | — |
| 0 (this device) | K140430 | 740 Select | Cas Medical Systems, Inc. | 2014 | — |
| +1 | K150620 | 740 Select | Cas Medical Systems, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 1 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 14 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130411 | 740 Select | 2013 |
| * | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsSummary page 1…s equivalent to the following devices: " CASMED 740 SELECT (Phase 1)Monitor (KI13041 1); " Masimo Corporation - Radical 7 Pulse Co-Oximeter (K 120657); * Covidien (Nellcor) - Bedside Respiratory Patient Monitoring System (K130320); * Exergen Corporati… | 2012 |
| * | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Summary page 1…3041 1); " Masimo Corporation - Radical 7 Pulse Co-Oximeter (K 120657); * Covidien (Nellcor) - Bedside Respiratory Patient Monitoring System (K130320); * Exergen Corporation - TemporalScanner Thermometer (KOI 1291; * PHASEIN AS (Masimo) Infrared Sides… | 2014 |
| * | K011291 | Temporalscanner Thermometer, Sensortouch | 2001 |
| * | K103604 | Isa CO2, Isa AX+, Isa or+Summary page 1…stem (K130320); * Exergen Corporation - TemporalScanner Thermometer (KOI 1291; * PHASEIN AS (Masimo) Infrared Sidestreamn Gas Analyzer (ISA) (K 103604); " PHASE[N AB (Masimo) Infrared Mainstream Gas Analyzer (IRMA) (K 123403); * Oridion (Covidien) Capn… | 2011 |
| Kept off the family tree | K123403 | FDA’s K123403 is Axsos Proximal Lateral Tibia Long Plates Our reading of the summary gave K123403, FDA’s number for Axsos Proximal Lateral Tibia Long Plates (Stryker Trauma AG). Its FDA name has none of the distinctive words the summary uses for the device it names, “PHASEIN AB (Masimo) Infrared Mainstream Gas Analyzer (IRMA)”. Kept off the family tree. Summary page 1…291; * PHASEIN AS (Masimo) Infrared Sidestreamn Gas Analyzer (ISA) (K 103604); " PHASE[N AB (Masimo) Infrared Mainstream Gas Analyzer (IRMA) (K 123403); * Oridion (Covidien) Capnostreamn2o (K0940 12) DESCRIPTION The 740… | 2013 |
| * | K094012 | CAPNOSTREAM20 with MICROMEDICO2 ModuleSummary page 1…Gas Analyzer (ISA) (K 103604); " PHASE[N AB (Masimo) Infrared Mainstream Gas Analyzer (IRMA) (K 123403); * Oridion (Covidien) Capnostreamn2o (K0940 12) DESCRIPTION The 740 SELECT is a rugged portable non-invasive multi-parameter devic… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150620 | 740 Select | 2015 | 0 |
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 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 6 months on median.
- 16 of the 145 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150620 (Cas Medical Systems, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130411.
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 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of: *Blood pressure and pulse rate of adult, pediatric and neonatal patients; *Functional oxygen saturation of arterial…
Read the full statement (196 words)
The 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of:
*Blood pressure and pulse rate of adult, pediatric and neonatal patients;
*Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and neonatal patients;
*Additionally the Masimo Rainbow SET technology provides noninvasive monitoring of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed on the 740 SELECT with the Masimo Rainbow SET option includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (P1), and/or Pleth Variability Index (PVI) indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused;
*Carbon Dioxide concentration of the expired and inspired breath and respiration rate of adult, pediatric, infant or neonatal patient and included, with the Oridion option, an Integrated Pulmonary Index (IPI);
*Intermittent predictive body temperature (oral, axillary, rectal) of adult, pediatric and neonatal patients;
*Infrared (over the temporal artery) measurement of body temperature of people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140430: 740 Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140430
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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