510(k) Report

510(k) · Cleared

Cleared

Siemens MICRO2 Pulse Oximeter

K913489510(k) TraditionalCleared Oct 30, 199185-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 Electronics · DQA Oximeter

Cleared on Oct 30, 1991 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 293 later devices descend from it.

Decided
Oct 30, 1991
Review
85 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

293 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 5 descendants cleared2012: 11 descendants cleared2009: 6 descendants cleared2004: 6 descendants cleared2006: 14 descendants cleared2010: 10 descendants cleared2005: 9 descendants cleared2011: 11 descendants cleared2007: 7 descendants cleared2016: 13 descendants cleared2015: 11 descendants cleared2013: 13 descendants cleared2017: 13 descendants cleared2008: 5 descendants cleared2018: 15 descendants cleared2026: 15 descendants cleared2014: 11 descendants cleared2021: 14 descendants cleared2020: 11 descendants cleared2022: 20 descendants cleared2019: 11 descendants cleared2023: 21 descendants cleared2025: 21 descendants cleared2024: 18 descendants cleared1990200020102020
  1. This deviceK913489 Siemens MICRO2 Pulse OximeterSiemens Medical Electronics · 1991
  2. Descendant · cites it directly · 292 of its ownK012770 Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002
  3. Descendant · 2 generations on · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
  4. Descendant · 3 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
  5. Descendant · 4 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
  6. Descendant · 5 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 293 descendants. See all descendants

Descendants cleared per year

2002: 22003: 52004: 62005: 92006: 142007: 72008: 52009: 62010: 102011: 112012: 112013: 132014: 112015: 112016: 132017: 132018: 152019: 112020: 112021: 142022: 202023: 212024: 182025: 212026: 15
2002high 21 (2023) · low 2 (2002)2026

Most influential descendants

Showing 5 of 293 · See all
  • K012770Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002 · cites it directly292descendants
  • K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · 2 generations on289descendants
  • K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 3 generations on280descendants
  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 4 generations on251descendants
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 5 generations on249descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913489Siemens MICRO2 Pulse OximeterSiemens Medical Electronics1991—
+1K012770Infinity MICRO2+Siemens Medical Solutions USA, Inc.2002—
+2K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…Siemens Medical Solutions USA, Inc.2002—
+3K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…Siemens Medical Solutions USA, Inc.2003—
+4K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004—
+5K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200350
200460
200590
2006140
200770
200850
200960
2010100
2011110
2012110
2013130
2014110
2015110
2016130
2017130
2018150
2019110
2020110
2021140
2022200
2023210
2024180
2025210
2026150
FIG. 1 — Lineage of K913489, 1991–2026Source: 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), 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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (293)

See all 293

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012770Infinity MICRO2+Siemens Medical Solutions USA, Inc.2002292

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?

  • Of its descendants, K012770 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 292 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

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
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

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

More from Siemens Medical Electronics

15 FDA decisions under this applicant name. See the company

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  • K920445Siemens Sirecust Penta System and AccessoriesSiemens Medical Electronics · 1993
  • K914765Siemens NP Noninvasive Blood Press Measurement SysSiemens Medical Electronics · 1992
  • K912070Siemens Radiotom 904 & 904E Electrosurgery UnitSiemens Medical Electronics · 1992

Recent decisions in DQA

The DQA category page

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  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K913489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913489: Siemens MICRO2 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913489

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026