510(k) · Cleared
ClearedDraeger MICRO2+ and Masimo Minisat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · DQA Oximeter
Cleared on Nov 25, 2003 as substantially equivalent to K030640 (Siemens Medical Solutions USA, Inc., 2003) and 2 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Nov 25, 2003
- Review
- 99 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K946306 (1995). 7 ancestors in all, the oldest K913489 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 3 generations backK980882 Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK012770 Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK030640 Siemens MICRO2+ with Vai SoftwareSiemens Medical Solutions USA, Inc. · 2003
- This deviceK032537 Draeger MICRO2+ and Masimo MinisatDraeger Medical Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −3 | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K012770 | Infinity MICRO2+ | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K030640 | Siemens MICRO2+ with Vai Software | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K032537 | Draeger MICRO2+ and Masimo Minisat | Draeger Medical Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K030640 | Siemens MICRO2+ with Vai SoftwareSummary page 1…II 870.2700 Ear Oximeter 74 DPZ II 870.2710 Lenally Marketed Device Identification: MICR02+, 51qk) K030640,KO12770 Masimo SET Radical Pulse Oximeter and LNOP Series Sensors, KO13792 Description of Modification: The release o… | 2003 |
| * | K012770 | Infinity MICRO2+ | 2002 |
| * | K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 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 as stated in the FDA summary.
https://510kreport.com/device/K032537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032537: Draeger MICRO2+ and Masimo Minisat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032537
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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