FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005— 510(k) K031260

Clearance details

Applicant

Abbott Diabetes Care, Inc.

Product code

Code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2003-04-21

Decision date

2003-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Alameda, CA, US

• K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more2026-08-27
• K262116 — TRUE METRIX Self Monitoring Blood Glucose System2026-07-23
• K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more2025-10-10
• K243060 — TeleRPM Gen2 Blood Glucose Monitoring System2025-01-30
• K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel2024-11-04

• K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System2024-04-23
• K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System2023-04-13
• K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System2023-03-03
• K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System2023-02-21
• K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System2022-05-26

Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →