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

LHO — Predicate Candidate Screening

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

103 daysmedian FDA review time

240 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K042733	STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM	Standard Imaging, Inc.	2004-11-15	45
K873956	ULTIMETER	Radiation Measurements, Inc.	1987-10-30	32
K860260	MULTI PURPOSE MODEL 76-903	Victoreen, Inc.	1986-05-07	103
K853754	MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901	Victoreen, Inc.	1986-05-07	240
K860100	MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902	Victoreen, Inc.	1986-04-22	102
K844620	BDS-3 BEAM DATA SCANNER	Varian Assoc., Inc.	1985-07-01	216
K845007	RFA-7 RADIATION FIELD ANALYZER	Varian Assoc., Inc.	1985-07-01	187
K834483	DIGI-X	Radiation Measurements, Inc.	1984-03-05	90

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