510(k) · Cleared
ClearedV-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 17, 2010 as substantially equivalent to K051038 (Ciriticare Systems, Inc., 2005) and 4 other predicates after a 44-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jun 17, 2010
- Review
- 44 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K982481 (1998). 16 ancestors in all, the oldest K911124 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 4 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 3 generations backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- 2 generations backK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- 1 generation backK092106 U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure…Taidoc Technology Corporation · 2010
- This deviceK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
- Descendant · cites it directly · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −4 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −3 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| −2 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| −1 | K092106 | U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor… | Taidoc Technology Corporation | 2010 | — |
| 0 (this device) | K101259 | V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 | Taidoc Technology Corporation | 2010 | — |
| +1 | K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model… | Taidoc Technology Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (6)
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 |
|---|---|---|---|
| * | K051038 | 506 Patient Monitor | 2005 |
| * | K911124 | 503 Pulse OximeterSummary page 2…3l1. 5. Substantial Equivalence Information: A. Predicate device name and k numnber: * 506 Patient Monitor (KO5 1Q38) * Oiimeter: 503 PULSE OXIMETER (K911124) Blood Glucose Meter: Clever Check TD-A131 Blood Glucos.e Mntrn System "103212) * Blood Glucose Test Str… | 1991 |
| * | K082169 | Pro Glucose Test StripSummary page 2…124) Blood Glucose Meter: Clever Check TD-A131 Blood Glucos.e Mntrn System "103212) * Blood Glucose Test Strip: TaiDoc Pro I Glucose Test Strip (K082 169) Page 2 3 2 of 3 * 1RThermomnet… | 2008 |
| * | K081445 | Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B Our reading of the summary gave K051445, FDA’s number for Milliken Silver Wound Dressings (Milliken Chemical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Fora ComfortScan Ear thermometer”. | 2008 |
| * | K092106 | U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model TD-3132…Summary page 3…3 2 of 3 * 1RThermomneter: Fora ComtbrtScan Ear thermometer (KOS 1445) NIBP:~U-RIGHT TD'3132 Blood Pressure Monitor (K(092106), B. Comparison with predicate: The V-TRUST TD-8002 Multi-Parameter Spot-Checklvlonitor has equivalent techn-olog… | 2010 |
| * | — | Clever Check TD-A131 Blood Glucose Monitoring System Named without a submission number | |
| † | K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 | 2018 | 0 |
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 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K172221 (Taidoc Technology Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051038.
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. 2010, 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?
The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2). The device is intended to be used by clinicians and medically qualified personnel. For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood. For blood pressure measurements, it is intended to be used to measure…
Read the full statement (113 words)
The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).
The device is intended to be used by clinicians and medically qualified personnel.
For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.
For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101259
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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