510(k) · Cleared
ClearedE.S Teck ( Electro Sensor Teck)
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 Feb 23, 2009 as substantially equivalent to K050620 (Dailycare Biomedical, Inc., 2005) and 2 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1997. 5 later devices descend from it.
- Decided
- Feb 23, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963725 (1997). 10 ancestors in all, the oldest K853124 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 2 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 1 generation backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- This deviceK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- Descendant · cites it directly · 4 of its ownK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- Descendant · 2 generations on · 2 of its ownK160956 LD-Oxi systemLd Technology, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK200141 Oxi-W SystemLd Technology, LLC · 2020
- Descendant · 4 generations on · 0 of its ownK253306 BioTracker 2.0Biotracker, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010 · cites it directly4descendants
- K160956LD-Oxi systemLd Technology, LLC · 2016 · 2 generations on2descendants
- K200141Oxi-W SystemLd Technology, LLC · 2020 · 3 generations on1descendant
- K253306BioTracker 2.0Biotracker, LLC · 2026 · 4 generations on0descendants
- K130056Patient MonitorLd Technology, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −2 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| 0 (this device) | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| +1 | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| +2 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
| +3 | K200141 | Oxi-W System | Ld Technology, LLC | 2020 | — |
| +4 | K253306 | BioTracker 2.0 | Biotracker, LLC | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K050620 | Readmyheart, Model RMH3.0Summary page 2…70.2780 Product Code JOM Classification: Class II Classification Panel: Cardiovascular /Anesthesiology 3. Predicate legally marketed devices Readmyheart (Model RMH 3.0) K050620 HRV module Applicant: DailyCare BioMedical Inc. Pulse Oximeter MD 300 I, K072825 Applicant: Beijing Choice Electronic Technology… | 2005 |
| * | K072825 | Fingertip Pulse Oximeter, Model MD300ISummary page 2…cular /Anesthesiology 3. Predicate legally marketed devices Readmyheart (Model RMH 3.0) K050620 HRV module Applicant: DailyCare BioMedical Inc. Pulse Oximeter MD 300 I, K072825 Applicant: Beijing Choice Electronic Technology Co., Ltd. Mc Pulse Photoelectric Plethysmograph K023238 Applicant: Meridian Co.,… | 2008 |
| * | K023238 | McpulseSummary page 2…ule Applicant: DailyCare BioMedical Inc. Pulse Oximeter MD 300 I, K072825 Applicant: Beijing Choice Electronic Technology Co., Ltd. Mc Pulse Photoelectric Plethysmograph K023238 Applicant: Meridian Co., Ltd. 4. Device Description Description of the features The ES Teck System is a programmable electro me… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102442 | E.S.O. (Electro Sensor Oxi) | 2010 | 4 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K102442 (Ld Technology, LLC, 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K050620.
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. 2009, 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?
Each module has specific feature and intended use 1. Pulse Oximeter: * 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. 2. Heart rate variability (HRV) * To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time…
Read the full statement (226 words)
Each module has specific feature and intended use
1. Pulse Oximeter:
* 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.
2. Heart rate variability (HRV)
* 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 ES Teck software.
The device is intended use only for adult subjects (> 20 years old)
This Oximeter is intended to be used in spot-checking (2 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 licensed practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083229: E.S Teck ( Electro Sensor Teck).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083229
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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