Atlas FDA

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

Retinalabs.Com · Predicate Candidate Screening

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

90 daysmedian FDA review time
259 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGERetinalabs.Com2000-12-22840
K000418PDT DOSECALCULATOR, MODEL 80000Retinalabs.Com2000-10-242590
K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHRetinalabs.Com2000-05-09880
K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001Retinalabs.Com2000-05-08900
K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10Retinalabs.Com2000-05-08900

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