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

Angiodynamics, Div. E-Z-Em, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time
494 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K961763PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1996-07-17713
K951509PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1995-06-16742
K951602PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1995-06-14923
K950907PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1995-05-17930
K933846ANGIOGRAPHY SYRINGE KITSAngiodynamics, Div. E-Z-Em, Inc.1994-12-134940
K923120MICROGUIDE LESION MARKING SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1992-09-01670

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