# K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 17, 2010 after 44 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K982481 (1998). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051038: 506 Patient Monitor, Ciriticare Systems, Inc. (2005)
- K911124: 503 Pulse Oximeter, Criticare Systems, Inc. (1991) Summary page 2.
- K082169: Pro Glucose Test Strip, Taidoc Technology Corporation (2008) Summary page 2.
- K081445: Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B, Taidoc Technology Corporation (2008). 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”.
- K092106: U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model TD-3132, TD-3132, Taidoc Technology Corporation (2010) Summary page 3.
- (no number) Clever Check TD-A131 Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101259
Methodology: https://510kreport.com/methodology