Atlas FDA

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

D&R X-Ray Products, Inc. · Predicate Candidate Screening

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

34 daysmedian FDA review time
66 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K862734CEILSTAND, MULTISTAND R & S AND THE BUCKYSTANDD&R X-Ray Products, Inc.1986-08-01110
K861941COLLIMATOR MODEL A280BLMD & MODEL A280BLMPD&R X-Ray Products, Inc.1986-07-25660
K861942COLLIMATOR MODEL A280BLE & MODEL A280-BLMD&R X-Ray Products, Inc.1986-07-25660
K861940RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-TD&R X-Ray Products, Inc.1986-05-2990
K850948TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITERD&R X-Ray Products, Inc.1985-04-10340

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