FDA product code · Clinical Chemistry · Class 2
NBW: System, Test, Blood Glucose, Over The Counter
NBW is FDA's product code for "System, Test, Blood Glucose, Over The Counter": a Class 2 device classified under 21 CFR 862.1345, reviewed by the Clinical Chemistry panel.
510(k) review time for NBW
Across 71 510(k) clearances under NBW decided from 2018-01-01 to 2026-10-06, the median was 193 days from FDA receipt to decision. Half took between 113 and 279 days, and 80% were decided within 380 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 113 |
| Median | 193 |
| 75th percentile | 279 |
| 80th percentile | 380 |
| 90th percentile | 501 |
| Slowest | 810 |
| Year | Median days | n |
|---|---|---|
| 2018 | 168 | 19 |
| 2019 | 127 | 10 |
| 2020 | 121 | 7 |
| 2021 | 465 | 7 |
| 2022 | 410 | 12 |
| 2023 | 193 | 5 |
| 2024 | 243 | 7 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NBW in the public FDA record
| 510(k) clearances, all years | 510 |
|---|---|
| Device recalls | 137 |
| Establishment listings | 830 |
| GUDID device identifiers | 1,529 |
Counts of records, not of devices or events. Adverse event reports for NBW are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NBW
5 FDA recognized consensus standards cite NBW, among them IEEE Std 11073-10417-2023; IEEE Std 11073-10417-2015; CLSI EP37 1st Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-148 IEEE Std 11073-10417-2023 — Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
- 13-90 IEEE Std 11073-10417-2015 — Health Informatics - Personal Health Device Communication Part 10417: Device Specialization - Glucose Meter
- 7-284 CLSI EP37 1st Edition — Supplemental Tables for Interference Testing in Clinical Chemistry
- 7-301 CLSI GP42 7th Edition — Collection of Capillary Blood Specimens
- 7-348 CLSI EP37 2nd Edition — Supplemental Tables for Interference Testing in Clinical Chemistry
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.