510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

740 Select

K150620510(k) TraditionalCleared May 8, 201559-day reviewClass II21 CFR 870.2300Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cas Medical Systems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on May 8, 2015 as substantially equivalent to K140430 (Cas Medical Systems, Inc., 2014) and 1 other predicate after a 59-day review. Its family tree reaches back 19 generations to 1994. 1 of the 178 devices in its family, counting itself, has a Class I recall. It has been recalled once.

Decided
May 8, 2015
Review
59 days
Class
Class II
Product code
MWI
Recalls
1
Predicates
2

Its longest line of descent runs back 19 generations to K941811 (1994). 177 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 178 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2013: 2 other ancestors2014: 1 other ancestor2011: 2 other ancestors2010: 2 other ancestors2009: 6 other ancestors2001: 5 other ancestors2012: 2 other ancestors2008: 2 other ancestors2006: 6 other ancestors2005: 7 other ancestors2004: 4 other ancestors2002: 10 other ancestors2007: 2 other ancestors2003: 3 other ancestors2000: 15 other ancestors1999: 12 other ancestors1998: 13 other ancestors1995: 10 other ancestors1994: 8 other ancestors1990: 5 other ancestors1986: 1 other ancestor1985: 1 other ancestor1997: 11 other ancestors, 1 with a Class I recall11996: 6 other ancestors1993: 4 other ancestors1992: 7 other ancestors1991: 6 other ancestors1987: 3 other ancestors1984: 1 other ancestor1989: 1 other ancestorK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×3: 3 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002) ×4: 4 generations cleared close together, K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003) ×2: 2 generations cleared close together, K040259 (2004), K041815 (2004) K051212 · Modification to LNCS Oximetry Sensors · Masimo Corporation · 2005 · recalledK101896 · Masimo LNCS/M-LNCS Oximetry Sensors · Masimo Corporation · 2010K111888 · Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors · Masimo Corporation · 2011K120657 · Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors · Masimo Corporation · 2012K140430 · 740 Select · Cas Medical Systems, Inc. · 20141980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 15 other ancestors4 generations back: 30 other ancestors5 generations back: 25 other ancestors6 generations back: 25 other ancestors, 1 with a Class I recall17 generations back: 13 other ancestors8 generations back: 8 other ancestors9 generations back: 27 other ancestors10 generations back: 8 other ancestors K140430 · 740 Select · Cas Medical Systems, Inc. · 2014K120657 · Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors · Masimo Corporation · 2012K111888 · Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors · Masimo Corporation · 2011K101896 · Masimo LNCS/M-LNCS Oximetry Sensors · Masimo Corporation · 2010K051212 · Modification to LNCS Oximetry Sensors · Masimo Corporation · 2005 · recalledK041815 · LNCS Oximetry Sensors · Masimo Corp. · 2004K040259 · Masimo Set Intellivue Pulse Oximeter Module · Masimo Corp. · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−15−10−50
  1. Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 15 generations between
  3. 3 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
  4. 2 generations backK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  5. 1 generation backK140430 740 SelectCas Medical Systems, Inc. · 2014
  6. This deviceK150620 740 SelectCas Medical Systems, Inc. · 2015
Show all 19 generations
  1. Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 18 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 17 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 16 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 15 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 14 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 13 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 12 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 11 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 10 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 9 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 8 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 7 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  14. 6 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
  15. 5 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
  16. 4 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
  17. 3 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
  18. 2 generations backK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  19. 1 generation backK140430 740 SelectCas Medical Systems, Inc. · 2014
  20. This deviceK150620 740 SelectCas Medical Systems, Inc. · 2015

Class I recalls in this family

View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−18K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−17K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−16K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−15K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−14K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−13K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−12K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−11K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−10K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−9K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−8K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−7K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004—
−6K041815LNCS Oximetry SensorsMasimo Corp.2004—
−5K051212Modification to LNCS Oximetry SensorsMasimo Corporation20055
−4K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation2010—
−3K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation2011—
−2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation2012—
−1K140430740 SelectCas Medical Systems, Inc.2014—
0 (this device)K150620740 SelectCas Medical Systems, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198610
198730
198910
199050
199160
199270
199340
199480
1995100
199660
1997111
1998130
1999120
2000150
200150
2002100
200330
200440
200570
200660
200720
200820
200960
201020
201120
201220
201320
201410
FIG. 1 — Lineage of K150620, 1994–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K140430740 Select
Summary page 4
…ion: Class II Substantially Equivalent Device(s): The 740 SELECT is equivalent to the following devices:  CASMED 740 SELECT Monitor (K140430);  Zoe Medical Nightingale Monitoring System (K130740) DESCRIPTION The 740 SE…
Cas Medical Systems, Inc.2014—
*K130740Nightingale Monitoring System
Summary page 4
…The 740 SELECT is equivalent to the following devices:  CASMED 740 SELECT Monitor (K140430);  Zoe Medical Nightingale Monitoring System (K130740) DESCRIPTION The 740 SELECT is a rugged portable non-invasive multi-parameter device used f…
Zoe Medical, Inc.2013—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 13, 2024Class IIZ-3099-2024Labeling designThis product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

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 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 6 months on median.
  • 24 of the 177 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

The 740 SELECT series of patient 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, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients. The 740 SELECT series…

Read the full statement (208 words)

The 740 SELECT series of patient 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, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.

The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:

• Blood pressure and pulse rate;

• Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate;

• Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);

• Electronic predictive and temporal artery temperature;

• ECG and heart rate derived from ECG;

• Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;

• Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K150620: 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/K150620

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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