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

IBJ — Predicate Candidate Screening

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

82 daysmedian FDA review time

161 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K874750	VIDEO ANALYZER 4000	Scientific Imaging, Inc.	1988-04-25	159
K874207	THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION	Intl. Remote Imaging Systems	1988-01-05	82
K874190	CELL COUNTING GRID GRATICULE	Portable Medical Laboratories, Inc.	1988-01-05	83
K864049	MCARTHUR MICROSCOPE, STANDARD METAL VERSION	Portable Medical Laboratories, Inc.	1986-10-29	12
K854735	MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.	Portable Medical Laboratories, Inc.	1985-12-10	15
K823040	PATHOLOGY INSTRUMENTATION & ACCESSORIES	Iris Remote Imaging Systems	1983-01-14	92
K822207	2XC MICROSCOPE	Amarel Precision Instruments, Inc.	1982-08-05	13
K821865	A O MICROSCOPE VIDEO SYSTEM	Warner-Lambert Co.	1982-07-14	20
K802818	PULLEN POCKET SCOPE	P.A. Research Corp.	1981-04-17	161

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