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

Dixon Medical, Inc. · Predicate Candidate Screening

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

35 daysmedian FDA review time
70 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903600ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-NDixon Medical, Inc.1990-10-17700
K903599ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-NDixon Medical, Inc.1990-10-17700
K903598ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-NDixon Medical, Inc.1990-10-17700
K903593ESPI APPLICATOR SLEEVE, #8410Dixon Medical, Inc.1990-09-12350
K903596ESPI REDUCER SLEEVE, #8415Dixon Medical, Inc.1990-09-12350
K903597ESPI MICRO SCISSORS, #8150Dixon Medical, Inc.1990-09-12350
K903592ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTHDixon Medical, Inc.1990-09-12350
K903601ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204Dixon Medical, Inc.1990-09-12350
K903595ESPI CLAW FORCEP, #8302, 10MM, 30CMDixon Medical, Inc.1990-09-12350
K903591ESPI HOOK/UNIVERSAL SCISSORS, # 8101Dixon Medical, Inc.1990-09-12350
K903602ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203Dixon Medical, Inc.1990-09-12350
K903594ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201Dixon Medical, Inc.1990-09-12350

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