510(k) · Cleared
ClearedMasimo Compatible Saturation Module, E-Masimo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · DQA Oximeter
Cleared on Jul 31, 2008 as substantially equivalent to K052755 (GE Healthcare, 2005) after a 30-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 31, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943456 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK943456 AS/3 Nellcor Compatible Saturation Moodule, M-NsatDatex Division Instrumentarium Corp. · 1994
- 2 generations backK020479 Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and…Datex-Ohmeda · 2002
- 1 generation backK052755 Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-NsatGE Healthcare · 2005
- This deviceK081870 Masimo Compatible Saturation Module, E-MasimoGE Healthcare Finland Oy · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943456 | AS/3 Nellcor Compatible Saturation Moodule, M-Nsat | Datex Division Instrumentarium Corp. | 1994 | — |
| −2 | K020479 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and Accessories | Datex-Ohmeda | 2002 | — |
| −1 | K052755 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat | GE Healthcare | 2005 | — |
| 0 (this device) | K081870 | Masimo Compatible Saturation Module, E-Masimo | GE Healthcare Finland Oy | 2008 | — |
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? (1)
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 |
|---|---|---|---|
| * | K052755 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-NsatSummary page 1…mes: 21 CFR 870.2700 Oximeter IDQAI 21 CFR 870.2710 Ear Oximeter (DPZ) Predicate Devices: K052755 Datex-Ohmeda S/5Tm Nellcor Compatible Saturation Module, E-NSAT and accessories DeviceDescription:… | 2005 |
| † | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or… | 2006 |
| † | K061185 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A Software | 2006 |
| † | K071020 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A Software | 2007 |
| † | K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software | 2008 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 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. 2008, this device’s year, is highlighted.
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 Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081870: Masimo Compatible Saturation Module, E-Masimo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081870
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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