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

International Remote Imaging Systems — Predicate Candidate Screening

3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K030600	AUTION JET AJ-4270 URINE ANALYZER	International Remote Imaging Systems	2003-07-11	136	0
K013783	AUTION MAX AX-4280 URINALYSIS SYSTEM	International Remote Imaging Systems	2002-01-18	65	0
K945913	IRISPEC URINE CHEMISTRY CONTROL PART A AND B	International Remote Imaging Systems	1995-04-05	124	2

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