Atlas FDA

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

Dutch Ophthalmic USA, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
175 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012821D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMDutch Ophthalmic USA, Inc.2001-10-22600
K010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMDutch Ophthalmic USA, Inc.2001-03-12610
K983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMDutch Ophthalmic USA, Inc.1999-03-031260
K980636FIBER OPTIC ENDOILLUMINATION PROBEDutch Ophthalmic USA, Inc.1998-05-20900
K973229D.O.R.C. HEXON ILLUMINATION SYSTEMDutch Ophthalmic USA, Inc.1997-11-25900
K973757D.O.R.C. SOLUX LIGHT SOURCEDutch Ophthalmic USA, Inc.1997-11-07360
K962135D.O.R.C. MICRODIATHERMY SYSTEMDutch Ophthalmic USA, Inc.1996-08-29870
K954842D.O.R.C. VFI/VFE SYSTEMDutch Ophthalmic USA, Inc.1996-04-151750
K940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.1994-07-181730
K902491ECKHARDT TEMPORARY KERATOPROSTHESISDutch Ophthalmic USA, Inc.1990-06-26210

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