Atlas FDA

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

Lunar Corp. — Predicate Candidate Screening

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

67 daysmedian FDA review time
169 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K001812PEDIATRIC REFERENCE DATALunar Corp.2000-07-10250
K001756LUNAR REPORT GENERATOR IILunar Corp.2000-07-06270
K000826PRODIGY LATERAL VIEW SOFTWARELunar Corp.2000-04-14310
K983724ORCA-DX BONE DENSITOMETERLunar Corp.1998-12-08470
K983564PRODIGY TOTAL BODY SOFTWARELunar Corp.1998-12-08560
K983262FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERSLunar Corp.1998-11-18620
K983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMLunar Corp.1998-11-18620
K983269FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMELunar Corp.1998-11-18620
K982267DPX-RX BONE DENSITOMETERLunar Corp.1998-08-18500
K974437EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARLunar Corp.1998-02-13810
K972517EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARELunar Corp.1997-11-181340
K965226EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARELunar Corp.1997-10-032770
K972053PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREALunar Corp.1997-08-08670
K970224PIXI BONE DENSITOMETERLunar Corp.1997-04-16850
K964307EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERSLunar Corp.1997-04-161690
K964263EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARELunar Corp.1996-11-07130
K961007EXPERT SPINE MORPHOTIETRY REFERENCELunar Corp.1996-07-251350
K961944LUNAR REPORT GENERATORLunar Corp.1996-07-03440
K960907ORCALunar Corp.1996-05-20760
K953032LUNAR DPX DENSITOMETERLunar Corp.1995-10-231150
K935454DPX TISSUE QUANTIFICATION OUTPUTLunar Corp.1995-10-197060
K950611EXPERT MORPHOMERTY SOFTWARDLunar Corp.1995-05-241030
K945526LUNAR EXPERTLunar Corp.1995-04-251660

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