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

Irex Corp. — Predicate Candidate Screening

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

83 daysmedian FDA review time

163 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K844404	IREX PS, PORTABLE SCANNER AND 118	Irex Corp.	1985-02-04	83
K843643	COLOR DOPPLER 880	Irex Corp.	1985-01-31	136
K842408	IREX 730 MECHANICAL SECTOR SCANNER	Irex Corp.	1984-11-29	163
K840139	IREX 720 SECTOR SCANNER	Irex Corp.	1984-05-09	126
K827370	IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM	Irex Corp.	1982-06-28	77
K813544	IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.	Irex Corp.	1982-02-05	46
K811246	DOPPLER ULTRASOUND BLOOD FLOWMETER	Irex Corp.	1981-08-12	99
K792525	IREX CARDIOPLAN	Irex Corp.	1979-12-27	21
K791317	IREX REAL TIME PHASED ARRAY SYSTEM	Irex Corp.	1979-09-17	67
K771372	SYSTEM II	Irex Corp.	1977-08-04	10

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