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

Marco Ophthalmic, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time
195 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943234MS-30 AUTOMATIC PERIMETERMarco Ophthalmic, Inc.1994-07-27210
K930438MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPSMarco Ophthalmic, Inc.1993-08-091950
K930442MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPSMarco Ophthalmic, Inc.1993-08-091950
K930444MARCO STANDARD KERATOMETERSMarco Ophthalmic, Inc.1993-08-091950
K930437MARCO STANDARD RADIUSGAUGESMarco Ophthalmic, Inc.1993-08-091950
K930439MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.1993-07-221770
K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.1993-07-061610
K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.1993-07-061610
K930443MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJEMarco Ophthalmic, Inc.1993-07-061610
K930447MARCO H AND TS-1 INSTRUMENT TABLESMarco Ophthalmic, Inc.1993-07-061610
K930440MARCO INTERNATIONAL STANDMarco Ophthalmic, Inc.1993-07-061610
K930449MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.1993-07-061610
K930448MARCO PROJECTION PERIMETERMarco Ophthalmic, Inc.1993-06-211460
K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.1993-06-211460
K921320ELIOS DIODE OPHTHALMIC LASERMarco Ophthalmic, Inc.1992-07-021050

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