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

Lunar — Predicate Candidate Screening

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

231 daysmedian FDA review time

454 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K914404	ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT	Lunar	1992-02-27	147
K915535	FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM	Lunar	1992-02-27	80
K905291	LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA	Lunar	1991-08-09	256
K904980	DPX-L AND DPX-ALPHA, MODIFICATION	Lunar	1990-12-05	33
K890121	MODIFIED DPX BONE DENSITOMETER	Lunar	1990-04-10	454
K884625	DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY	Lunar	1989-06-23	231

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