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

Optical Micro Systems, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
211 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950218OMS SLIMLINE PHACO HANDPIECEOptical Micro Systems, Inc.1995-07-171790
K946054DIPLOMAXOptical Micro Systems, Inc.1995-07-112110
K935223OPHTHALMIC SURGICAL SYSTEMOptical Micro Systems, Inc.1994-03-141330
K935226I/V POLEOptical Micro Systems, Inc.1994-02-161070
K935003ELECTRIC I/V POLE OR EIVP2Optical Micro Systems, Inc.1994-01-25980
K870068ASPIRATION REVERSAL CONTROL (ARC) MODULEOptical Micro Systems, Inc.1987-02-12350
K844373O.M.S. ULTRA-PHACOOptical Micro Systems, Inc.1985-12-194010
K844448OMS/GONVERS RETINAL PERFORATOROptical Micro Systems, Inc.1985-08-212780
K844895OMS SILICONE OIL INJECTOROptical Micro Systems, Inc.1985-06-241890
K844467OMS CRYOOptical Micro Systems, Inc.1985-02-22950
K844715VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SYOptical Micro Systems, Inc.1985-01-22560
K844510OMS SCISSORSOptical Micro Systems, Inc.1984-12-11210
K844374O.M.S. GUILLOTINE CUTTEROptical Micro Systems, Inc.1984-12-11280
K833820MACHEMER/TANO ROTATINGOptical Micro Systems, Inc.1984-01-04630
K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.1982-02-0590
K813274BLOOD POOL & SUBVETINAL FLUID ASPIRATOROptical Micro Systems, Inc.1982-02-05740
K813500OMS INFUSION-ASPIRATION HANDLEOptical Micro Systems, Inc.1982-02-04520
K813481OMS INFUSION CANNULA ASSEMBLEOptical Micro Systems, Inc.1982-01-22520
K813483OMS ANTERIOR CHAMBER INFUSION NEEDLEOptical Micro Systems, Inc.1982-01-22520
K813545HYPOSERMIC NEEDLESOptical Micro Systems, Inc.1982-01-12220
K813273EMERGENCY POWER PAC (EMPAC)Optical Micro Systems, Inc.1981-12-31410

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