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

Xre Corp. — Predicate Candidate Screening

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

80 daysmedian FDA review time

265 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K973744	UNICATH SP BI-PLANE (MODEL M269 & M289)	Xre Corp.	1997-12-29	89
K961193	FULL FRAME ZOOM SYSTEM	Xre Corp.	1996-06-17	88
K960998	XRE COLLIMATOR	Xre Corp.	1996-04-03	22
K945449	UNICATH LLU ANGIOGRAPHIC SYSTEM	Xre Corp.	1995-02-27	112
K936002	CINEMAC QAS	Xre Corp.	1994-09-09	268
K933460	DVFX, MODEL M256	Xre Corp.	1994-04-07	265
K924828	BI-N	Xre Corp.	1992-12-17	80
K923654	POLY DIAGNOST CDX	Xre Corp.	1992-11-20	122
K913685	UNICATH EP.	Xre Corp.	1991-11-07	80
K912416	ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM	Xre Corp.	1991-08-28	89
K892849	UNICATH A	Xre Corp.	1989-08-09	113
K875184	UNICATH LAB	Xre Corp.	1988-01-29	38
K874113	OMNI DIAGNOST	Xre Corp.	1987-11-16	38
K874114	TRAUMA TABLE II	Xre Corp.	1987-11-16	38
K854085	OMNI PLANE SYSTEM	Xre Corp.	1985-10-28	21
K852952	TRAUMA STAND	Xre Corp.	1985-09-26	77
K853535	TRAUMA TABLE	Xre Corp.	1985-09-11	19
K850455	QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM	Xre Corp.	1985-05-06	89
K837515	DENTAL CASSETTE HOLDERS	Xre Corp.	1983-06-28	63
K761339	RADIAL TRAVEL SPEC. PROCEDURES TABLE	Xre Corp.	1977-01-05	9

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