Atlas FDA

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

James L. Geraci & Associates, Inc. · Predicate Candidate Screening

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

24 daysmedian FDA review time
76 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853927LASE SYSTEM IIJames L. Geraci & Associates, Inc.1985-10-16220
K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.1982-02-24420
K820079AIRMED PNEUMATIC EQUIP. FILTRA/CONTROLJames L. Geraci & Associates, Inc.1982-02-05240
K820078DRAPE, SURGICALJames L. Geraci & Associates, Inc.1982-02-04230
K811698CARL ZEISS INN MYRINGOTOMY TUBE LINEJames L. Geraci & Associates, Inc.1981-08-31760

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