Atlas FDA

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

Xanmed Corp. — Predicate Candidate Screening

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

133 daysmedian FDA review time
268 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864623OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KITXanmed Corp.1987-01-14500
K844595ORTHOPEDIC CUSTOM SURGICAL KITXanmed Corp.1985-08-212680
K844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITXanmed Corp.1985-08-012480
K844593CARDIOVASCULAR CUSTOM SURGICAL KITXanmed Corp.1985-06-212070
K844594NEURO CUSTOM SURGICAL KITXanmed Corp.1985-06-131990
K851906SURGICAL EYE PACKXanmed Corp.1985-05-21200
K844597MISCELLANEOUS GENERAL SURGICAL CUSTOM KITXanmed Corp.1985-04-081330
K843642SUBCLAVIAN LEAD INTRODUCER SYSXanmed Corp.1984-10-23360
K843641CATHETER INTRODUCER SYSTEMXanmed Corp.1984-10-23360

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