Atlas FDA

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

Radiation Products Design, Inc. · Predicate Candidate Screening

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

40 daysmedian FDA review time
210 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150382Radio Therapy Treatment ChairRadiation Products Design, Inc.2015-09-162100
K800760BITE BLOCK SYSTEMRadiation Products Design, Inc.1980-05-28540
K800761POINT TO POINT LEVELRadiation Products Design, Inc.1980-05-14400
K800791MYLAR WINDOW-TABLE INSERT PANELRadiation Products Design, Inc.1980-05-14360
K800792ADJUSTABLE HEAD & FACE HOLDERRadiation Products Design, Inc.1980-05-14360
K800759ELEV. BACK SUPPORT W/ADJ. ARM POSITIONERRadiation Products Design, Inc.1980-05-14400
K800790TENNIS RACKET-TABLE INSERT PANELRadiation Products Design, Inc.1980-05-14360
K791178MYVACET 5-07, 7-00 AND 9-40Radiation Products Design, Inc.1979-09-17840

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