cobas pulse blood glucose monitoring system— 510(k) K252323

Name: FDA 510(k) clearance K252323
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K252323 for cobas pulse blood glucose monitoring system, Substantially Equivalent on 2026-06-12. Applicant: Roche Diagnostics. Device class: 2.

Summary

Roche Diagnostics' cobas pulse blood glucose monitoring system is filed under PZI, prescription-use blood glucose meters for near-patient testing. The record doesn't list the system's components.

Class II, 21 CFR 862.1345. Clinical Chemistry is both the classification panel and the review panel. The submission type is listed as Dual Track.

Roche filed from Indianapolis, Indiana. Review took 322 calendar days (July 25, 2025 to June 12, 2026).

Clearance details

Applicant: Roche Diagnostics
Product code: Product code PZI
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2025-07-25
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PZI

view all

K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System2024-11-19
K220272 — cobas pulse blood glucose monitoring system2024-04-26
K232075 — StatStrip Glucose Hospital Meter System2024-02-23
K200788 — Assure Titanium Blood Glucose Monitoring System2022-05-23
K182549 — StatStrip Xpress 2 Glucose Hospital Meter System2018-12-13

More clearances from Roche Diagnostics

view all

DEN260027 — Elecsys HBsAg II quant II RxDx2026-10-20
K260221 — Elecsys EBV EBNA IgG2026-10-02
K260232 — Elecsys EBV VCA IgG2026-10-02
K260233 — Elecsys EBV IgM2026-10-02
K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19

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