Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LZF — Predicate Candidate Screening

7 FDA 510(k) clearances under this product code; the 50 most recent screened below.

320 daysmedian FDA review time

627 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192785	OptiScanner® 5000 Glucose Monitoring System	Optiscan Biomedical Corporation	2020-02-05	128	0
K162042	OptiScanner 5000 Glucose Monitoring System	Optiscan Biomedical Corp.	2017-10-16	448	0
K011238	RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM	Metracor Technologies, Inc.	2002-01-08	260	0
K951739	PUMP/BLOOD CHEMISTRY MONITOR	Via Medical Corp.	1996-02-28	320	0
K922997	VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.	Via Medical Corp.	1994-01-11	568	1
K920438	VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM	Via Medical Corp.	1993-10-22	627	0
K882830	INFUSION PUMP	Pemlab Corp.	1988-12-30	175	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda