510(k) · Cleared
Recalled · Class I · 2023Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor
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 Mar 12, 2010 as substantially equivalent to K062576 (GE Healthcare, 2006) and 3 other predicates after an 84-day review. Its family tree reaches back 4 generations to 2001. 3 of the 13 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Mar 12, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 4 (4 Class I)
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010463 (2001). 10 ancestors in all, the oldest K962127 (1996). 2 later devices descend from it, 2 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
- 3 generations backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
- 2 generations backK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002 · Recalled (Class I)
- 1 generation backK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Recalled (Class I)
- This deviceK093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal…GE Healthcare Finland Oy · 2010
- Descendant · cites it directly · 0 of its ownK250931 Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)…Unimed Medical Supplies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK132696 Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010463 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires | Datex-Ohmeda, Inc. | 2001 | 1 |
| −3 | K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with… | Datex-Ohmeda | 2001 | 1 |
| −2 | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series… | Datex-Ohmeda, Inc. | 2002 | Class I |
| −1 | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 | Datex-Ohmeda, Inc. | 2004 | Class I |
| 0 (this device) | K093881 | Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap… | GE Healthcare Finland Oy | 2010 | — |
| +1 | K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed… | Unimed Medical Supplies, Inc. | 2025 | — |
| +1 | K132696 | Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor | GE Healthcare Finland Oy | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2025 | 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.
3 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? (4)
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 |
|---|---|---|---|
| * | K062576 | Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and…Summary page 1…ximeter Sensors and Interconnect Cables Classification Names: 21 CFR 870.2700, 21 CFR 870.271 0 Product Code: DQA, DPZ Predicate Device(s): K062576 S/5 E-PSM(P) Module and Accessories K04083 1 TruSat Pulse Oximeter and Accessories… | 2006 |
| * | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Summary page 1…870.2700, 21 CFR 870.271 0 Product Code: DQA, DPZ Predicate Device(s): K062576 S/5 E-PSM(P) Module and Accessories K04083 1 TruSat Pulse Oximeter and Accessories K02 1955 3800 Series and 3900 Series Oximeters and Accessori… | 2004 |
| * | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Summary page 1…icate Device(s): K062576 S/5 E-PSM(P) Module and Accessories K04083 1 TruSat Pulse Oximeter and Accessories K02 1955 3800 Series and 3900 Series Oximeters and Accessories K992323 Cardiocap 5 and Accessories… | 2002 |
| * | K992323 | Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and AccessoriesSummary page 1…4083 1 TruSat Pulse Oximeter and Accessories K02 1955 3800 Series and 3900 Series Oximeters and Accessories K992323 Cardiocap 5 and Accessories Device Description: Pulse oximeter sensors and interconnect cables connecting to… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2023 | Class I | Z-2030-2023 | 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-2028-2023 | 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-2029-2023 | 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-2027-2023 | Device Design | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
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.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- 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
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K250931 (Unimed Medical Supplies, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062576.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
TS-F-D The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds) TS-E-D The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds) TS-W-D The Wrap Sensor is a…
Read the full statement (238 words)
TS-F-D
The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds)
TS-E-D
The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)
TS-W-D
The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds)
Contraindications
Sensitivity to adhesive tape may cause an allergic reaction.
TS-SE-3
The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range All patients
Contraindications
Sensitivity to adhesive tape may cause an allergic reaction.
TS-AF-10 and TS-AF-25
The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients
Contraindications
Sensitivity to adhesive tape may cause an allergic reaction.
Trusignal SpO2 Interconnect cables
The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093881: Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093881
Report an extraction error
Are you the manufacturer?
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