510(k) · Cleared
ClearedE.S.O. (Electro Sensor Oxi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · DQA Oximeter
Cleared on Sep 10, 2010 as substantially equivalent to K083229 (Ld Technology, LLC, 2009) after a 15-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 10, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). 11 ancestors in all, the oldest K853124 (1985). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 3 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 2 generations backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- 1 generation backK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- This deviceK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- Descendant · cites it directly · 2 of its ownK160956 LD-Oxi systemLd Technology, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK200141 Oxi-W SystemLd Technology, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK253306 BioTracker 2.0Biotracker, LLC · 2026
- Descendant · cites it directly · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K160956LD-Oxi systemLd Technology, LLC · 2016 · cites it directly2descendants
- K200141Oxi-W SystemLd Technology, LLC · 2020 · 2 generations on1descendant
- K253306BioTracker 2.0Biotracker, LLC · 2026 · 3 generations on0descendants
- K130056Patient MonitorLd Technology, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −3 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| 0 (this device) | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| +1 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
| +2 | K200141 | Oxi-W System | Ld Technology, LLC | 2020 | — |
| +3 | K253306 | BioTracker 2.0 | Biotracker, LLC | 2026 | — |
| +1 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K083229 | E.S Teck ( Electro Sensor Teck)Summary page 3…le side effects: Side effects or adverse reactions are none known to date. 9. Substantial equivalence Predicate legally marketed device Electro Sensor Teck (Model PEMS) K083229 Applicant: LD Technology LLG. Product code MWI Similarities: Substantial equivalence V Same intended use V Same technologi… | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K160956 (Ld Technology, LLC, 2016) has gone furthest, with 2 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. 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?
* To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. * To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. * To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of…
Read the full statement (208 words)
* To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
* To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.
* To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability.
The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis.
The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the ESO software.
The device is intended use only for adult subjects (> 20 years old)
This Oximeter is intended to be used in spot-checking (5 minutes)
The device is intended use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended use in support life and not for continuously monitoring
The system will be use by practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102442 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102442: E.S.O. (Electro Sensor Oxi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102442
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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