TeleRPM Gen2 Blood Glucose Monitoring System
FDA 510(k) K243060 · Guangdong Transtek Medical Electronics Co., Ltd.
510(k) numberK243060
Submission
- Device name
- TeleRPM Gen2 Blood Glucose Monitoring System
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd.
Zhongshan, CN - Received
- September 27, 2024
- Decision date
- January 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
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| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 01/19/2024SE |
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|---|---|---|
| K241351 | Blood Pressure Monitor (TMB-2092-G)DXN · Special | 08/21/2024SE |
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| K240254 | Blood Pressure Monitor (TMB-2296-BT)DXN · Traditional | 05/31/2024SE |
| K240102 | Blood Pressure Monitor (TMB-2287-B)DXN · Traditional | 04/29/2024SE |
| K233130 | Blood Pressure MonitorDXN · Traditional | 12/20/2023SE |
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| K232621 | Blood pressure monitorDXN · Traditional | 11/22/2023SE |
| K223374 | Blood Pressure MonitorDXN · Traditional | 06/30/2023SE |
| K220676 | Blood Pressure MonitorDXN · Traditional | 08/29/2022SE |
| K202891 | Blood Pressure MonitorDXN · Traditional | 03/09/2021SE |
Questions and answers
When was TeleRPM Gen2 Blood Glucose Monitoring System cleared by the FDA?
TeleRPM Gen2 Blood Glucose Monitoring System (K243060) received a 510(k) decision of Substantially Equivalent on January 30, 2025, 125 days after the submission was received.
What is the product code of K243060?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.