510(k) · Cleared

Recalled · 2008

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

K033048510(k) SpecialCleared Jun 1, 2004246-day reviewClass II21 CFR 870.1025Recalls 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. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jun 1, 2004 as substantially equivalent to K982776 (Cas Medical Systems, Inc., 1998) and 5 other predicates after a 246-day review. Its family tree reaches back 6 generations to 1997. 1 of the 294 devices in its family, counting itself, has a Class I recall. 272 later devices descend from it. It has been recalled once.

Decided: Jun 1, 2004
Review: 246 days
Class: Class II
Product code: MHX
Recalls: 1
Predicates: 6

Its longest line of descent runs back 6 generations to K962603 (1997). 21 ancestors in all, the oldest K893221 (1990). 272 later devices descend from it, 4 citing it directly. 1 of the 294 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
1 generation backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
This deviceK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004
Descendant · cites it directly · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
Descendant · 5 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009

Showing 5 of 272 descendants. See all descendants

Descendants cleared per year

2005high 24 (2022) · low 1 (2008)2026

Class I recalls in this family

K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 272 · See all

K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · cites it directly264descendants
K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 5 generations on155descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−5	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−4	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−3	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−2	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1
−1	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2002	—
0 (this device)	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	—
+1	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
+2	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
+3	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—
+4	K082268	CAPNOSTREAM20 with Integrated Pulmonary Index	Oridion Capnography, Inc.	2009	9
+5	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1991	1	0
1992	1	0
1993	1	0
1995	2	0
1996	1	0
1997	1	0
1998	4	0
1999	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2007	2	0
2008	1	0
2009	7	0
2010	8	0
2011	6	0
2012	15	0
2013	15	0
2014	18	1
2015	13	0
2016	11	0
2017	16	0
2018	16	0
2019	17	0
2020	16	0
2021	12	0
2022	24	0
2023	16	0
2024	20	0
2025	19	0
2026	16	0

FIG. 1 — Lineage of K033048, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K982776	9303 Neonatal/Adult Vital Signs Monitor Summary page 2 …EQUIVALENCE The CAS 740 Monitor is equivalent to the following devices: · CAS 9303 Neonatal / Adult Vital Signs Monitor (K982776); ·. CAS 9001 EMS NIBP Monitor (K982135); *. CAS 9002 EMS NIBP / SpO2 Monitor (K980879);…	Cas Medical Systems, Inc.	1998	—
*	K982135	Oscillomate Ems Nibp Monitor Model 9001 Summary page 2 …0 Monitor is equivalent to the following devices: · CAS 9303 Neonatal / Adult Vital Signs Monitor (K982776); ·. CAS 9001 EMS NIBP Monitor (K982135); *. CAS 9002 EMS NIBP / SpO2 Monitor (K980879); · Nellcor Puritan Bennett N-550 Pulse Oximeter (…	Cas Medical Systems, Inc.	1998	—
*	K980879	Oscillomate Nibp / SP02 Ems Monitor Summary page 2 …CAS 9303 Neonatal / Adult Vital Signs Monitor (K982776); ·. CAS 9001 EMS NIBP Monitor (K982135); . CAS 9002 EMS NIBP / SpO2 Monitor (K980879); · Nellcor Puritan Bennett N-550 Pulse Oximeter (K021090); * Nellcor Puritan Bennett N-595 Pulse Ox…	Cas Medical Systems, Inc.	1998	—
*	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter Summary page 2 …·. CAS 9001 EMS NIBP Monitor (K982135); . CAS 9002 EMS NIBP / SpO2 Monitor (K980879); · Nellcor Puritan Bennett N-550 Pulse Oximeter (K021090); * Nellcor Puritan Bennett N-595 Pulse Oximeter (K012891); *. Masimo Set 2000 Pulse Oximeter / accessor…	Nellcor Puritan Bennett, Inc.	2002	—
*	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables… Summary page 2 …EMS NIBP / SpO2 Monitor (K980879); · Nellcor Puritan Bennett N-550 Pulse Oximeter (K021090); ** Nellcor Puritan Bennett N-595 Pulse Oximeter (K012891); *. Masimo Set 2000 Pulse Oximeter / accessories (K990966) DESCRIPTION…	Nellcor Puritan Bennett, Inc.	2002	1
*	K990966	Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor… Summary page 2 …nnett N-550 Pulse Oximeter (K021090); ** Nellcor Puritan Bennett N-595 Pulse Oximeter (K012891); *. Masimo Set 2000 Pulse Oximeter / accessories (K990966) DESCRIPTION The CAS 740 Monitor is a replacement monitor based on the existing 930…	Masimo Corp.	1999	—

Also cleared against K982776: 6 other devices →

What descends from it? (272)

See all 272

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

Number	Device	Applicant	Decided	Descendants
K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…	Cas Medical Systems, Inc.	2005	264
K130411	740 Select	Cas Medical Systems, Inc.	2013	6
K072516	Midmark Diagnostics Iqmark Vital Signs Monitor	Midmark Diagnostics Group	2007	2
K160667	Anybattery C2 Rechargeable Battery	Anybattery, Inc.	2017	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2008	Not classified	Z-2203-2008	Software change control	Software: Audible alarm may be silenced if changed from the factory setting

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.

K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 11 months on median.
4 of the 21 ancestors have a recall of any class.
Of its descendants, K050844 (Cas Medical Systems, Inc., 2005) has gone furthest, with 264 descendants of its own.
6 other devices also cite its predicate K982776.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)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 CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033048 · printed Nov 5, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033048

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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