Atlas FDA

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

Opti-Centre Laboratories · Predicate Candidate Screening

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

73 daysmedian FDA review time
175 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K043129PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULOpti-Centre Laboratories2005-01-12610
K010256ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULOpti-Centre Laboratories2001-03-26560
K001227ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICOpti-Centre Laboratories2000-06-29730
K992589RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCOpti-Centre Laboratories1999-08-26240
K983496RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCONOpti-Centre Laboratories1999-03-291750
K974599ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DOpti-Centre Laboratories1998-03-02830

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