Atlas FDA

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

Lunar Radiation Corp. — Predicate Candidate Screening

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

113 daysmedian FDA review time
294 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K873296DPX BONE DENSITOMETERLunar Radiation Corp.1988-06-062940
K810159BONE MINERAL ANALYZER CONTROLLERLunar Radiation Corp.1981-02-12220
K810140DUAL-PHOTON TOTAL BODY BONE MINERAL ANALunar Radiation Corp.1981-02-12220
K802181WISCONSIN BONE MINERAL ANALYZERLunar Radiation Corp.1980-12-311130
K802180WISCONSIN DUAL-PHOTON BONE ANALYZERLunar Radiation Corp.1980-12-311130
K802182WISCONSIN HEART RATE MONITORLunar Radiation Corp.1980-10-31520

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