510(k) · Cleared
ClearedANS1 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 May 22, 2014 as substantially equivalent to K113264 (Ld Technology, LLC, 2012) after a 93-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- May 22, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001907 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 3 generations backK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
- 2 generations backK110948 Health Care System SoftwareTaidoc Technology Corporation · 2011
- 1 generation backK113264 Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 2012
- This deviceK140412 ANS1 SoftwareLd Technology, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −3 | K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | 2007 | — |
| −2 | K110948 | Health Care System Software | Taidoc Technology Corporation | 2011 | — |
| −1 | K113264 | Electro Sensor Complex Software (ES Complex Software) | Ld Technology, LLC | 2012 | — |
| 0 (this device) | K140412 | ANS1 Software | Ld Technology, LLC | 2014 | — |
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 |
|---|---|---|---|
| * | K113264 | Electro Sensor Complex Software (ES Complex Software) | 2012 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K113264.
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. 2014, 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?
ANSI Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer) When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANSI software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data…
Read the full statement (138 words)
ANSI Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer)
When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANSI software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management.
The ANSI software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results.
The device provides values. It is the physician responsibility to make proper judgment based on these numbers.
The ANSI software data are stored in back up files located on the PC.
The software is intended for use only with adult subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140412: ANS1 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140412
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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