Product code NBW: 510(k) clearances and predicates
Product code NBW covers CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System. FDA lists 510 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
510 clearances on file under product code NBW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 12 |
| 2023 | 5 |
| 2024 | 7 |
| 2025 | 2 |
| 2026 so far | 2 |
Recent clearances
Newest NBW clearances in the FDA index, with applicant and decision date:
- K260545, CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System, applicant Ascensia Diabetes Care, decided 2026-08-27. FDA record
- K262116, TRUE METRIX Self Monitoring Blood Glucose System, applicant Trividia Health, Inc., decided 2026-07-23. FDA record
- K250085, On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System, applicant ACON Laboratories, Inc., decided 2025-10-10. FDA record
- K243060, TeleRPM Gen2 Blood Glucose Monitoring System, applicant Guangdong Transtek Medical Electronics Co., Ltd., decided 2025-01-30. FDA record
- K240637, RIGHTEST Blood Glucose Monitoring System Max Tel, applicant Bionime Corporation, decided 2024-11-04. FDA record
- K240640, Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System, applicant Sejoy Biomedical Co., Ltd., decided 2024-10-08. FDA record
- K241787, CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System, applicant Ascensia Diabetes Care U.S., Inc., decided 2024-08-27. FDA record
- K222126, VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System, applicant Vivachek Biotech (Hangzhou) Co., Ltd., decided 2024-08-16. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include TRUE METRIX Self Monitoring Blood Glucose System, On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System. Watch new NBW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code NBW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent NBW clearances include CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System.
How many 510(k) clearances use product code NBW?
510 at the time this page was generated, from openFDA records.
How do I find a predicate device under NBW?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new NBW clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.