Contour Next Usb Blood Glucose Monitoring System
FDA 510(k) K121087 · Bayer Healthcare
510(k) numberK121087
Submission
- Device name
- Contour Next Usb Blood Glucose Monitoring System
- Applicant
- Bayer Healthcare
Mishawaka, IN, US - Received
- April 10, 2012
- Decision date
- June 28, 2012
- 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 |
|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)NUH · Traditional | 03/07/2018SE |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH · Traditional | 12/22/2015SE |
| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | 11/25/2015SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | 09/23/2015SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | 06/23/2014SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
| K110587 | Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…LFR · Traditional | 03/28/2012SE |
| K111268 | Contour (R) Next Blood Glucose Monitoring SystemLFR · Traditional | 03/06/2012SE |
Questions and answers
When was Contour Next Usb Blood Glucose Monitoring System cleared by the FDA?
Contour Next Usb Blood Glucose Monitoring System (K121087) received a 510(k) decision of Substantially Equivalent on June 28, 2012, 79 days after the submission was received.
What is the product code of K121087?
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.