VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
FDA 510(k) K172221 · Taidoc Technology Corporation
510(k) numberK172221
Submission
- Device name
- VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
- Applicant
- Taidoc Technology Corporation
New Taipei City, TW - Received
- July 24, 2017
- Decision date
- June 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
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| 510(k) | Device | Decision |
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| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track | 11/19/2024SE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional | 06/16/2022SE |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional | 04/05/2022SE |
| K190579 | TD-4183 Blood Glucose Monitoring SystemNBW · Traditional | 06/04/2019SE |
| K182934 | FORA P100 Blood Pressure Monitoring SystemDXN · Traditional | 02/12/2019SE |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional | 12/19/2018SE |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemPTC · Traditional | 12/10/2018SE |
| K181588 | POPS! one Blood Glucose Monitoring SystemNBW · Traditional | 11/30/2018SE |
| K172733 | TD-1035 ThermometerFLL · Traditional | 10/22/2018SE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special | 07/12/2018SE |
Questions and answers
When was VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 cleared by the FDA?
VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (K172221) received a 510(k) decision of Substantially Equivalent on June 6, 2018, 317 days after the submission was received.
What is the product code of K172221?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.