510(k) · Cleared
ClearedDatex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · DQA Oximeter
Cleared on Oct 13, 2005 as substantially equivalent to K020479 (Datex-Ohmeda, 2002) after a 13-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Oct 13, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943456 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943456 AS/3 Nellcor Compatible Saturation Moodule, M-NsatDatex Division Instrumentarium Corp. · 1994
- 1 generation backK020479 Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and…Datex-Ohmeda · 2002
- This deviceK052755 Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-NsatGE Healthcare · 2005
- Descendant · cites it directly · 0 of its ownK081870 Masimo Compatible Saturation Module, E-MasimoGE Healthcare Finland Oy · 2008
Most influential descendants
Showing 1 of 1 · See all- K081870Masimo Compatible Saturation Module, E-MasimoGE Healthcare Finland Oy · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943456 | AS/3 Nellcor Compatible Saturation Moodule, M-Nsat | Datex Division Instrumentarium Corp. | 1994 | — |
| −1 | K020479 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and Accessories | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K052755 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat | GE Healthcare | 2005 | — |
| +1 | K081870 | Masimo Compatible Saturation Module, E-Masimo | GE Healthcare Finland Oy | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K020479 | Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and AccessoriesSummary page 2…S:5™ Neticor Compatible Saturation Module, E-NSAT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NSAT Module (K020479). The E-NSAT module has the following similartties compared to the predicate M-NSAT (K020479): e Identical intended use and indi… | 2002 |
| † | K040113 | Sandman SD20 Amplifier | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081870 | Masimo Compatible Saturation Module, E-Masimo | 2008 | 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 11 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081870 (GE Healthcare Finland Oy, 2008) has gone furthest, with 0 descendants of its own.
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 Datex-Ohmeda S/5 Tm Nellcor Compatible Saturation Module, E-NSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients. The device is indicated for use by qualified medical personnel only.
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/K052755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052755: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052755
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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