Atlas FDA

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

Dio-Med Corp. — Predicate Candidate Screening

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

223 daysmedian FDA review time
707 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933525DIOMED 25 25W SURGICAL DIODE LASERDio-Med Corp.1994-03-012230
K931776DIOMED 25 25W SURGICAL DIODE LASERDio-Med Corp.1993-10-191930
K931212DIOMED 25 25W SURGICAL DIODE LASERDio-Med Corp.1993-09-231970
K914519DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLICDio-Med Corp.1993-09-167070
K914520DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICATDio-Med Corp.1993-01-224700
K914521DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICATDio-Med Corp.1993-01-154630
K813267DISPOSABLE DIAPHRAGM DOMESDio-Med Corp.1981-12-14240

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