Atlas FDA

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

Angiomedics, Inc. — Predicate Candidate Screening

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

95 daysmedian FDA review time
187 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMOAngiomedics, Inc.1987-12-151230
K872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETERAngiomedics, Inc.1987-09-14770
K872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICEAngiomedics, Inc.1987-09-14830
K863342SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETERAngiomedics, Inc.1987-03-031870
K861238ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALVAngiomedics, Inc.1986-07-161050
K852872ANGIOMEDICS SOFTIP CATHETERAngiomedics, Inc.1985-10-11950
K850271ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULARAngiomedics, Inc.1985-04-03700
K834275SOFTIP CATHETERAngiomedics, Inc.1984-02-04580

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