Atlas FDA

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

PQH — Predicate Candidate Screening

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

203 daysmedian FDA review time
386 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.2026-06-122030
K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC2020-11-183860
K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.2020-07-301770
K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC2018-05-041330
K161723ulrich Transfer SetUlrich GmbH & Co. KG2016-12-211820
K133147BRACCO INJEENERING TRANSFER SETBracco Injeneering S.A.2014-06-202460

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