510(k) · Cleared
ClearedTrusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip 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 Aug 2, 2011 as substantially equivalent to K101871 (GE Healthcare Finland Oy, 2010) after a 217-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Aug 2, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K101871 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK101871 Trusignal SPO2 Fingertip SensorGE Healthcare Finland Oy · 2010
- This deviceK103802 Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor…GE Healthcare Finland Oy · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101871 | Trusignal SPO2 Fingertip Sensor | GE Healthcare Finland Oy | 2010 | — |
| 0 (this device) | K103802 | Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor; Trusignal R… | GE Healthcare Finland Oy | 2011 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101871 | Trusignal SPO2 Fingertip SensorSummary page 1…Pulse Oximeter Sensors Classification Names: 21CFR870.2700 Product Code: DQA Predicate Device(s): K 10 1871 TruSignal® SpO2 FingerTip Sensors K882609 Philips Ml 192A Reusable SpO2 sensor… | 2010 |
| Kept off the family tree | K882609 | FDA’s K882609 is Models M1175A & M1176A Component Monitoring System Our reading of the summary gave K882609, FDA’s number for Models M1175A & M1176A Component Monitoring System (Waltham Div. Hewlett Packard). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Ml 192A Reusable SpO2 sensor”. Kept off the family tree. Summary page 1…Product Code: DQA Predicate Device(s): K 10 1871 TruSignal® SpO2 FingerTip Sensors K882609 Philips Ml 192A Reusable SpO2 sensor Device Description: Pulse oximeter sensors connecting to patient monitor… | 1989 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103802: Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103802
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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