510(k) · Cleared
ClearedV-Trust Model TD-2202 Portable Ecg Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · DPS Electrocardiograph
Cleared on Mar 1, 2011 as substantially equivalent to K071085 (Micro-Star International Co., Ltd., 2007) and 1 other predicate after a 270-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 1, 2011
- Review
- 270 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950944 (1996). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 2 generations backK993617 Digitrakplus Holter RecorderBraemar Corp. · 1999
- 1 generation backK071085 E3-80 Portable Ecg Recorder & AnalyzerMicro-Star International Co., Ltd. · 2007
- This deviceK101569 V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation · 2011
- Descendant · cites it directly · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
- Descendant · cites it directly · 0 of its ownK131572 Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd. · 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 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −2 | K993617 | Digitrakplus Holter Recorder | Braemar Corp. | 1999 | — |
| −1 | K071085 | E3-80 Portable Ecg Recorder & Analyzer | Micro-Star International Co., Ltd. | 2007 | — |
| 0 (this device) | K101569 | V-Trust Model TD-2202 Portable Ecg Recorder | Taidoc Technology Corporation | 2011 | — |
| +1 | K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model… | Taidoc Technology Corporation | 2018 | — |
| +1 | K131572 | Micro Ambulatory Ecg Recorder | Dimetek Digital Medical Technologies, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071085 | E3-80 Portable Ecg Recorder & AnalyzerSummary page 2…cording (in non-compressed format). 5. Substantial Equivalence Information: A. Predicate device name and k number: 0 E3-80 Portable ECG Recorder &Analyzer (K071085) 0 HCG-801 portable EGG Monitor (K060766) B. Comparison with predicate: The V-TRUST TD-2202 Portable EGG Recorde… | 2007 |
| * | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Summary page 2…l Equivalence Information: A. Predicate device name and k number: 0 E3-80 Portable ECG Recorder &Analyzer (K071085) 0 HCG-801 portable EGG Monitor (K060766) B. Comparison with predicate: The V-TRUST TD-2202 Portable EGG Recorder has equivalent technological characteristics… | 2006 |
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 15 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K172221 (Taidoc Technology Corporation, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The V-TRUST TD-2202 portable EGG recorder is intended for recording and displaying EGG data of adult patients who are concerned about their heart rhythm. A patient can either equip a five lead-wires EGG cable to take a long term monitoring; or choose to use event reading option when feeling any heart condition occur. This recorder allows the patient to record their EGG data in SD memory card and playback the data for analysis by a physician or those knowledgeable about EGG morphology, rhythm, and arrhythmia.
The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101569: V-Trust Model TD-2202 Portable Ecg Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101569
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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