Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

EAK · Predicate Candidate Screening

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

41 daysmedian FDA review time
241 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952233CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628Victoreen, Inc.1995-06-16350
K944445ED CORP RADIATION SCREENMed Corp.1995-05-112410
K944772MULTIPLE ED1600 SERIES RADIATION SHIELDSImage Diagnostics, Inc.1994-10-20230
K896949MOBILE X-RAY PERSONNEL PROTECTIVE SCREENSInnovative Products Mfg.1990-02-16650
K861019CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELDPhase One Disign Co.1986-04-02150
K850814MODULAR X-RAY BARRIERSVictoreen, Inc.1985-04-10410
K850816LEAD PLASTIC VIEWING PANELSVictoreen, Inc.1985-04-10410

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