510(k) Report

510(k) · Cleared

Cleared

740 Select

K130411510(k) TraditionalCleared May 29, 201399-day reviewClass II21 CFR 870.2300

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 29, 2013 as substantially equivalent to K033048 (Cas Medical Systems, Inc., 2004) after a 99-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it.

Decided
May 29, 2013
Review
99 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K962603 (1997). 22 ancestors in all, the oldest K893221 (1990). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1998: 4 other ancestors1997: 1 other ancestor1995: 2 other ancestors1993: 1 other ancestor1990: 2 other ancestors1996: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor2017: 1 descendant cleared2021: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant clearedK962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999×2: 2 generations cleared close together, K012891 (2002), K021090 (2002) K033048 · Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS · Cas Medical Systems, Inc. · 2004 · recalled1990200020102020
  1. Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
  3. 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
  4. 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
  5. 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
  6. 2 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
  7. 1 generation backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
  8. This deviceK130411 740 SelectCas Medical Systems, Inc. · 2013
  9. Descendant · cites it directly · 2 of its ownK171751 SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for…Capsule Technologie Sas · 2017
  10. Descendant · cites it directly · 1 of its ownK140430 740 SelectCas Medical Systems, Inc. · 2014
  11. Descendant · cites it directly · 0 of its ownK200160 740 SafeSATZoe Medical, Inc. · 2021
  12. Descendant · 2 generations on · 0 of its ownK190468 Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation · 2019
  13. Descendant · 2 generations on · 0 of its ownK180734 SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 12018: 12019: 12021: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas · 2017 · cites it directly2descendants
  • K140430740 SelectCas Medical Systems, Inc. · 2014 · cites it directly1descendant
  • K200160740 SafeSATZoe Medical, Inc. · 2021 · cites it directly0descendants
  • K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation · 2019 · 2 generations on0descendants
  • K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962603Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp.1997—
−6K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp.1998—
−5K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998—
−4K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999—
−3K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…Nellcor Puritan Bennett, Inc.20021
−2K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002—
−1K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…Cas Medical Systems, Inc.20041
0 (this device)K130411740 SelectCas Medical Systems, Inc.2013—
+1K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot…Capsule Technologie Sas2017—
+1K140430740 SelectCas Medical Systems, Inc.2014—
+1K200160740 SafeSATZoe Medical, Inc.2021—
+2K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation2019—
+2K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199110
199210
199310
199520
199610
199710
199840
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
201810
201910
202110
FIG. 1 — Lineage of K130411, 1997–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in MWI? 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? (1)

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
*K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…
Summary page 2
…0411 page 2of 4 EQUIVALENCE (Predicate;Device) The 740 SELECT is equivalent to the following device: +* CAS 740 Series Monitor (K033048) DESCRIPTION The 740 SELECT Series Monitor is a portable and-rugged noninvasive multi-parameter device used for spot checki…
Cas Medical Systems, Inc.20041

Also cleared against K033048: 3 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172
K140430740 SelectCas Medical Systems, Inc.20141
K200160740 SafeSATZoe Medical, Inc.20210

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 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 5 of the 22 ancestors have a recall of any class.
  • Of its descendants, K171751 (Capsule Technologie Sas, 2017) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K033048.

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. 2013, 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 is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult, pediatric and neonatal patients. The Monitor features world class technology to facilitate the monitoring of non-invasive blood pressure, pulse rate, functional arterial oxygen saturation (SpO2) and body temperature in a variety of clinical environments.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K130411: 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/K130411

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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