FDA product code NBW: System, Test, Blood Glucose, Over The Counter
NBW is the FDA product code for system, test, blood glucose, over the counter. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 510 510(k) submissions under NBW, 28 in the last five years, from 130 different applicants. The average 510(k) review took 195 days (median 153); 190 days on average over the last three years. FDA has posted 137 recalls for NBW devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Blood Glucose, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for NBW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 25 | 258 |
| 2018 | 19 | 167 |
| 2019 | 10 | 153 |
| 2020 | 7 | 145 |
| 2021 | 7 | 416 |
| 2022 | 12 | 426 |
| 2023 | 5 | 264 |
| 2024 | 7 | 263 |
| 2025 | 2 | 198 |
| 2026 | 2 | 110 |
Compare with all 510(k) review times · Search every NBW clearance
Top NBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Taidoc Technology Corporation | 65 | 2022-06-16 |
| I-Sens, Inc. | 21 | 2023-08-10 |
| Bionime Corporation | 18 | 2024-11-04 |
| Apex BioTechnology Corp. | 18 | 2022-12-21 |
| Abbott Diabetes Care, Inc. | 18 | 2017-09-27 |
125 more applicants have NBW clearances. See the full list in Caduvo.
Most recent NBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260545 | Ascensia Diabetes Care | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | 2026-08-27 | 190 |
| K262116 | Trividia Health, Inc. | TRUE METRIX Self Monitoring Blood Glucose System | 2026-07-23 | 30 |
| K250085 | ACON Laboratories, Inc. | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | 2025-10-10 | 270 |
| K243060 | Guangdong Transtek Medical Electronics Co., Ltd. | TeleRPM Gen2 Blood Glucose Monitoring System | 2025-01-30 | 125 |
| K240637 | Bionime Corporation | RIGHTEST Blood Glucose Monitoring System Max Tel | 2024-11-04 | 243 |
Recalls for NBW devices
137 product recalls in 75 recall events; 9 initiated in the last five years and 18 still open. Most recent: 2026-02-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 16 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code NBW?
NBW is the FDA product code for system, test, blood glucose, over the counter. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is NBW?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBW?
Across 510 cleared submissions the average was 195 days from receipt to decision (median 153).
Which companies have the most NBW clearances?
Taidoc Technology Corporation (65); I-Sens, Inc. (21); Bionime Corporation (18); Apex BioTechnology Corp. (18); Abbott Diabetes Care, Inc. (18).
Have NBW devices been recalled?
Yes: 137 product recalls across 75 recall events; the most recent began 2026-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NBW
- Run a recall and safety report across every NBW manufacturer
- Watch product code NBW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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