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

Oculo-Plastik, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time
117 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.2013-01-31550
K112176SILICONE SPHERESOculo Plastik, Inc.2011-09-15490
K073293DURETTE IMPLANTOculo Plastik, Inc.2008-03-191170
K040689EYE SPHERE IMPLANTSOculo Plastik, Inc.2004-06-10860
K934834EPTFE SHEET COVERING FOR OCULAR IMPLANTOculo Plastik, Inc.1994-05-052090
K915630OPHTIMPLANTOculo Plastik, Inc.1992-03-02760
K901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESESOculo Plastik, Inc.1990-05-22810
K900929PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERALOculo Plastik, Inc.1990-05-18800
K900928COX MALAR EMINENCE IMPLANTSOculo Plastik, Inc.1990-05-15770
K900927CODERE-DURETTE ORBITAL FLOOR IMPLANTOculo Plastik, Inc.1990-05-15770
K900930SPIVEY-ALLEN ORBITAL FLOOR IMPLANTOculo Plastik, Inc.1990-05-15770
K900080NEW IOWA MOTILITY IMPLANTOculo Plastik, Inc.1990-03-23780
K900081NEW ALLEN IMPLANTOculo Plastik, Inc.1990-03-23780

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