510(k) · Cleared
Recalled · Class I · 2023Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · DPZ Oximeter, Ear
Cleared on Sep 2, 2004 as substantially equivalent to K021955 (Datex-Ohmeda, Inc., 2002) after a 155-day review. Its family tree reaches back 3 generations to 2001. 4 of the 33 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Sep 2, 2004
- Review
- 155 days
- Class
- Class II
- Product code
- DPZ
- Recalls
- 5 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010463 (2001). 5 ancestors in all, the oldest K962127 (1996). 27 later devices descend from it, 4 citing it directly. 4 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
- 2 generations backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
- 1 generation backK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002 · Recalled (Class I)
- This deviceK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004
- Descendant · cites it directly · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · 2 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · 2 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · cites it directly20descendants
- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 2 generations on11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 2 generations on10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 3 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010463 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires | Datex-Ohmeda, Inc. | 2001 | 1 |
| −2 | K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with… | Datex-Ohmeda | 2001 | 1 |
| −1 | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series… | Datex-Ohmeda, Inc. | 2002 | Class I |
| 0 (this device) | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 | Datex-Ohmeda, Inc. | 2004 | — |
| +1 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +2 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +2 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +3 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +4 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Summary page 1…the FDA cleared and currently marketed Datex-Ohmeda 3800 Series and 3900 Series Pulse Oximeters and Accessories with TruTrak Plus Enhancements (K021955). The TruSat pulse oximeter is indicated for spot-checking and continuous monitoring of functional oxyg… | 2002 |
What descends from it? (27)
See all 274 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2023 | Class I | Z-2026-2023 | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| May 19, 2023 | Class I | Z-2031-2023 | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| May 19, 2023 | Class I | Z-2032-2023 | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| Apr 8, 2011 | Not classified | Z-3206-2011 | Device Design | The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for system or components to start on fire or explode (general… |
| Apr 29, 2010 | Not classified | Z-1814-2010 | Component design/selection | GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards. It is possible that the external power supply could leak electrical current. This current… |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K073203 (Ge Medical Systems Information Technologies, 2007) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K021955.
How does its category compare?
All DPZ devicesDPZ Oximeter, Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPZ
FDA has decided no DPZ device since 2007.
Median 510(k) review, days · DPZ
Too few DPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DPZ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPZ
1in 2025
MAUDE reports naming product code DPZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 1 | 13 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion.
These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040831
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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