510(k) · Cleared

Cleared

Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC 8000, SC 7000, SC 9000XL

K033957510(k) SpecialCleared May 14, 2004144-day reviewClass II21 CFR 870.1025

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

Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 14, 2004 as substantially equivalent to K031340 (Siemens Medical Solutions USA, Inc., 2003) and 5 other predicates after a 144-day review. Its family tree reaches back 5 generations to 1995. 233 later devices descend from it.

Decided: May 14, 2004
Review: 144 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K946306 (1995). 21 ancestors in all, the oldest K900598 (1990). 233 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
4 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
3 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
2 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
1 generation backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
This deviceK033957 Infinity Modular Monitors VF4 Modifications with Scio, Models Delta…Draeger Medical Systems, Inc. · 2004
Descendant · cites it directly · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
Descendant · 2 generations on · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
Descendant · 3 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
Descendant · 4 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
Descendant · 4 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006

Showing 5 of 233 descendants. See all descendants

Descendants cleared per year

2005high 21 (2023) · low 2 (2005)2026

Most influential descendants

Showing 5 of 233 · See all

K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · cites it directly230descendants
K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · 2 generations on222descendants
K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 3 generations on221descendants
K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 4 generations on211descendants
K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 4 generations on188descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K946306	Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System	Siemens Medical Solutions USA, Inc.	1995	—
−4	K982730	SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor	Siemens Medical Solutions USA, Inc.	1998	—
−3	K983632	Siemens SC 8000 Bedside Monitor	Siemens Medical Solutions USA, Inc.	1998	—
−2	K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…	Siemens Medical Solutions USA, Inc.	2002	—
−1	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
0 (this device)	K033957	Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL…	Draeger Medical Systems, Inc.	2004	—
+1	K051628	Infinity Monitors with Scio Modifications	Draeger Medical Systems, Inc.	2005	—
+2	K053204	Intellivue Gas Modules, Models G5 M1019A and G1 M1013A	Draeger Medical AG & Co. Kgaa	2006	—
+3	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2
+4	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
+4	K062283	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…	Philips Medical Systems North America, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	3	0
1991	2	0
1992	1	0
1993	1	0
1996	2	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2002	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	8	0
2007	4	0
2008	4	0
2009	5	0
2010	6	0
2011	8	0
2012	10	0
2013	11	0
2014	9	0
2015	8	0
2016	9	0
2017	11	0
2018	13	0
2019	9	0
2020	9	0
2021	14	0
2022	19	0
2023	21	0
2024	18	0
2025	21	0
2026	14	0

FIG. 1 — Lineage of K033957, 1995–2026Source: 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.

Planning a device in MHX? 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
*	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio Summary page 1 …Arrhythmia detector & Alarm 74DSI II. 21 CFR 870.1025 Legally Marketed Device Identification: fNFINITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/…	Siemens Medical Solutions USA, Inc.	2003	—
*	K983632	Siemens SC 8000 Bedside Monitor Summary page 1 …74DSI II. 21 CFR 870.1025 Legally Marketed Device Identification: fNFINITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification:…	Siemens Medical Solutions USA, Inc.	1998	—
*	K990563	Siemens SC 8000 Bedside Monitor with Advanced Communication Option Summary page 1 …II. 21 CFR 870.1025 Legally Marketed Device Identification: fNFINITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The INFIN…	Siemens Medical Solutions USA, Inc.	1999	—
*	K003243	Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL Summary page 1 …ntification: fNFINITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The INFINITY Modular monitor VF4 software release includes a modification in s…	Siemens Medical Solutions USA, Inc.	2000	—
*	K982730	SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor Summary page 1 …ion: fNFINITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The INFINITY Modular monitor VF4 software release includes a modification in support o…	Siemens Medical Solutions USA, Inc.	1998	—
*	K980882	Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor Summary page 1 …ITY Modular Monitors with Scio K03 1340 fNFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K03 1340, K003243/K982730/ K980882 Description of Modification: The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio ga…	Siemens Medical Solutions USA, Inc.	1998	—

Also cleared against K031340: 5 other devices →

What descends from it? (233)

See all 233

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

Number	Device	Applicant	Decided	Descendants
K051628	Infinity Monitors with Scio Modifications	Draeger Medical Systems, Inc.	2005	230
K042904	Infinity Kappa XLT	Draeger Medical Systems, Inc.	2005	28

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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
None of the 21 ancestors has a recall.
Of its descendants, K051628 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 230 descendants of its own.
5 other devices also cite its predicate K031340.

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 INFINITY Modular monitors are capable of monitoring: * Heart rate · Respiration rate * Invasive pressure · Non-invasive pressure * Arrhythmia · Temperature · Cardiac output · Arterial oxygen saturation * Pulse rate * Apnea * ST Segment Analysis · 12-Lead ST Segment Analysis * tcpO2/tcpCO2 IEG signals E * FiO2 The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The modules continuously measure the content of C02…

Read the full statement (267 words)

The INFINITY Modular monitors are capable of monitoring:

* Heart rate

· Respiration rate

* Invasive pressure

· Non-invasive pressure

* Arrhythmia

· Temperature

· Cardiac output

· Arterial oxygen saturation

* Pulse rate

* Apnea

* ST Segment Analysis

· 12-Lead ST Segment Analysis

* tcpO2/tcpCO2

IEG signals

* FiO2

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The modules continuously measure the content of C02, N20, 02 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via an MIB protocol converter.

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

MRI Compatibility Statement:

The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033957: Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC 8000, SC 7000, SC 9000XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033957

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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