510(k) · Cleared
ClearedElectro Sensor Complex Software (ES Complex Software)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 2, 2012 as substantially equivalent to K110948 (Taidoc Technology Corporation, 2011) after a 119-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 2, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001907 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 2 generations backK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
- 1 generation backK110948 Health Care System SoftwareTaidoc Technology Corporation · 2011
- This deviceK113264 Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 2012
- Descendant · cites it directly · 0 of its ownK140412 ANS1 SoftwareLd Technology, LLC · 2014
- Descendant · cites it directly · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
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 |
|---|---|---|---|---|---|
| −3 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −2 | K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | 2007 | — |
| −1 | K110948 | Health Care System Software | Taidoc Technology Corporation | 2011 | — |
| 0 (this device) | K113264 | Electro Sensor Complex Software (ES Complex Software) | Ld Technology, LLC | 2012 | — |
| +1 | K140412 | ANS1 Software | Ld Technology, LLC | 2014 | — |
| +1 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K110948 | Health Care System SoftwareSummary page 3…software KI 10948. Applicant: TaiDoc Technology Corporation. Product codes NBW, DXN, FLL The substantial equivalence with the Heath care system software K 110948 is based upon: The same intended use and Different uploaded data, and the information submitted;… | 2011 |
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? (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 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140412 (Ld Technology, LLC, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-OS, galvanic skin response device and d) ES-BC. Analyzer body composition
When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management.
The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113264: Electro Sensor Complex Software (ES Complex Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113264
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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