510(k) · Cleared
ClearedDatex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · DQA Oximeter
Cleared on Nov 6, 1998 after a 17-day review. The FDA summary names its predicate without a number. 4 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 17 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 6 citing it directly. 4 of the 47 devices in this family, counting this one, have a Class I recall.
- This deviceK983684 Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse OximetersDatex-Ohmeda, Inc. · 1998
- Descendant · cites it directly · 28 of its ownK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 27 of its ownK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · 4 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · 4 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · See all- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Datex-Ohmeda, Inc. · 2002 · cites it directly28descendants
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 2 generations on27descendants
- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 3 generations on20descendants
- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 4 generations on11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983684 | Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters | Datex-Ohmeda, Inc. | 1998 | — |
| +1 | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series… | Datex-Ohmeda, Inc. | 2002 | Class I |
| +2 | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 | Datex-Ohmeda, Inc. | 2004 | Class I |
| +3 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +4 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +4 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2004 | 7 | 1 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 1 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 1 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | Datex-Ohmeda 3800 Pulse Oximeter Named without a submission number |
What descends from it? (46)
See all 466 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &… Class I | 2002 | 28 |
| K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | 2005 | 9 |
| K041522 | Flexi-Stat Disposable Adhesive SPO2 Sensors | 2004 | 2 |
| K041647 | Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)… | 2004 | 2 |
| K041964 | Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and… | 2004 | 0 |
| K041644 | Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)… | 2004 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021955 (Datex-Ohmeda, Inc., 2002) has gone furthest, with 28 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-Chmeda 3900/3900P Pulse Oximeters measure arterial oxygen saturation and pulse rate noninvasively using Datex-Ohmeda disposable and reusable finger and ear Sensors.
Additionally, the Datex-Ohmeda 3900/3300P Pulse Oximeters measure Relative Perfusion Index™ pulsatile value, which is an indicator of relative perfusion at the sensor sife.
US federal and Canadian laws restrict the sale of this device by or on the order of a licensed medical practitioner.
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/K983684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983684
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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