DeviceClearance

Product code NBW— Clinical Chemistry

POGO Automatic Blood Glucose Monitoring System

Classification name
System, Test, Blood Glucose, Over The Counter
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Total cleared
510
First cleared
Most recent

Market context for product code NBW

FDA has cleared 510 devices under product code NBW between 2001 and 2026, filed by 130 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NBW

Adverse events under product code NBW

product code NBW
Death
18
Injury
4,740
Malfunction
42,679
Other
6
Total
47,443

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NBW

1–100 of 510

Data sourced from openFDA. This site is unofficial and independent of the FDA.