510(k) · Cleared
ClearedLD-Oxi system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jul 6, 2016 as substantially equivalent to K102442 (Ld Technology, LLC, 2010) after a 92-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 6, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963725 (1997). 12 ancestors in all, the oldest K853124 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 4 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 3 generations backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- 2 generations backK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- 1 generation backK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- This deviceK160956 LD-Oxi systemLd Technology, LLC · 2016
- Descendant · cites it directly · 1 of its ownK200141 Oxi-W SystemLd Technology, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK253306 BioTracker 2.0Biotracker, LLC · 2026
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 |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −4 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −3 | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| −1 | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| 0 (this device) | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
| +1 | K200141 | Oxi-W System | Ld Technology, LLC | 2020 | — |
| +2 | K253306 | BioTracker 2.0 | Biotracker, LLC | 2026 | — |
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 |
|---|---|---|
| 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K102442 | E.S.O. (Electro Sensor Oxi)Summary page 4…duct Codes: MWI and DQA. Classification: Class II Classification Panel: Cardiovascular /Anesthesiology 3. Predicate legally marketed device Electro Sensor Oxi (ESO) K102442 Applicant: LD Technology LLC Product codes: MWI and DQA 4. Device Description The LD-Oxi System is a programmable electro med… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200141 | Oxi-W System | 2020 | 1 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K200141 (Ld Technology, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102442.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
LD-Oxi system is intended for use: 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…
Read the full statement (211 words)
LD-Oxi system is intended for use:
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 analysis 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 LD-Oxi 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/K160956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160956: LD-Oxi system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160956
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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