Atlas FDA

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

Transworld X-Ray Corp. — Predicate Candidate Screening

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

42 daysmedian FDA review time
92 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892657SENSIMATTransworld X-Ray Corp.1989-06-23710
K890066STAR 36Transworld X-Ray Corp.1989-03-28780
K873283MODEL C2-5000 OVERHEAD TUBE SUPPORTTransworld X-Ray Corp.1987-09-10240
K872980MAM-CP X-RAY APPARATUSTransworld X-Ray Corp.1987-08-27280
K872357TRANSWORLD 360V, MODEL A1-4040Transworld X-Ray Corp.1987-07-15270
K841923DCX-100 CHEST UNIT-GL-5000MTransworld X-Ray Corp.1984-08-10920
K827582MODIFIED X-RAY TABLETransworld X-Ray Corp.1982-07-09420

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