BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
FDA 510(k) K220421 · Apex BioTechnology Corp.
510(k) numberK220421
Submission
- Device name
- BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
- Applicant
- Apex BioTechnology Corp.
Hsinchu, CN - Received
- February 14, 2022
- Decision date
- November 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code NBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| 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 |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| 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 |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring SystemPTC · Traditional | 04/04/2025SE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW · Special | 12/21/2022SE |
| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | 08/25/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 04/06/2022SE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring SystemNBW · Special | 03/29/2022SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 10/15/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | 09/15/2021SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | 12/18/2018SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | 11/28/2018SE |
| K170267 | BGM009 Plus Blood Glucose Monitoring SystemNBW · Special | 03/09/2017SE |
Questions and answers
When was BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System cleared by the FDA?
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (K220421) received a 510(k) decision of Substantially Equivalent on November 4, 2022, 263 days after the submission was received.
What is the product code of K220421?
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.