510(k) · Cleared

Cleared

Infinity MICRO2+

K012770510(k) TraditionalCleared Jul 23, 2002340-day reviewClass II21 CFR 870.2700

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

Siemens Medical Solutions USA, Inc. · DQA Oximeter

Cleared on Jul 23, 2002 as substantially equivalent to K913489 (Siemens Medical Electronics, 1991) and 1 other predicate after a 340-day review. Its family tree reaches back 2 generations to 1995. 292 later devices descend from it.

Decided: Jul 23, 2002
Review: 340 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K946306 (1995). 3 ancestors in all, the oldest K913489 (1991). 292 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
1 generation backK980882 Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
This deviceK012770 Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
Descendant · 2 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
Descendant · 3 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
Descendant · 4 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 5 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 292 descendants. See all descendants

Descendants cleared per year

2002high 21 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 292 · See all

K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · cites it directly289descendants
K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on280descendants
K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 3 generations on251descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on249descendants
K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 5 generations on247descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K946306	Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System	Siemens Medical Solutions USA, Inc.	1995	—
−1	K980882	Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor	Siemens Medical Solutions USA, Inc.	1998	—
0 (this device)	K012770	Infinity MICRO2+	Siemens Medical Solutions USA, Inc.	2002	—
+1	K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…	Siemens Medical Solutions USA, Inc.	2002	—
+2	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
+3	K041956	Emg - Essential Gas Module, Model M1013A	Draeget Medical AG & Co. Kgaa	2004	—
+4	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+5	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	5	0
2004	6	0
2005	9	0
2006	14	0
2007	7	0
2008	5	0
2009	6	0
2010	10	0
2011	11	0
2012	11	0
2013	13	0
2014	11	0
2015	11	0
2016	13	0
2017	13	0
2018	15	0
2019	11	0
2020	11	0
2021	14	0
2022	20	0
2023	21	0
2024	18	0
2025	21	0
2026	15	0

FIG. 1 — Lineage of K012770, 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 DQA? 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 DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K913489	Siemens MICRO2 Pulse Oximeter Summary page 1 …Number Oximeter I 74DQA I I1 870.2700 3. Predicate Device Identification: MICRO^ 510(k) K913489 SC 7000/9000XL K980882 Other Relevant Submissions SC 9000…	Siemens Medical Electronics	1991	—
*	K980882	Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor Summary page 1 …I 74DQA I I1 870.2700 3. Predicate Device Identification: MICRO^ 510(k) K913489 SC 7000/9000XL K980882 Other Relevant Submissions SC 9000 K946306 SC 9000 Neonatal…	Siemens Medical Solutions USA, Inc.	1998	—

What descends from it? (292)

See all 292

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

Number	Device	Applicant	Decided	Descendants
K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…	Siemens Medical Solutions USA, Inc.	2002	289
K030640	Siemens MICRO2+ with Vai Software	Siemens Medical Solutions USA, Inc.	2003	1
K032537	Draeger MICRO2+ and Masimo Minisat	Draeger Medical Systems, Inc.	2003	0

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 7 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K022889 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 289 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The MICR02+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012770 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012770: Infinity MICRO2+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012770

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026