510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162042Substantially Equivalent

OptiScanner 5000 Glucose Monitoring System

Optiscan Biomedical Corp., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162042 is the FDA 510(k) clearance record for OptiScanner 5000 Glucose Monitoring System, a class II device, cleared for Optiscan Biomedical Corp. on under FDA product code LZF (Pump, Infusion, Analytical Sampling). FDA records list 2 510(k) clearances for Optiscan Biomedical Corp., from to . As of , FDA records show no recalls naming K162042.

Clearance record

Decision date
Received
(448 days to decision)
Product code
LZF Pump, Infusion, Analytical Sampling
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Optiscan Biomedical Corp. 24590 Clawiter Rd., Hayward CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZF

Trailing 12 months

FDA records hold no clearances under product code LZF in the trailing twelve months.

FDA records show no clearances under product code LZF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260