Atlas FDA

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

Douglas James Donaldson Compliance Services · Predicate Candidate Screening

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

90 daysmedian FDA review time
112 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912987CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODEDouglas James Donaldson Compliance Services1991-10-281120
K912284BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIFDouglas James Donaldson Compliance Services1991-08-191040
K905453CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HANDDouglas James Donaldson Compliance Services1991-03-05900
K905115BIOVISION ENDOCULAR PROBEDouglas James Donaldson Compliance Services1991-02-11900
K904366CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATORDouglas James Donaldson Compliance Services1990-10-19250

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