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

Zeiss Humphrey System — Predicate Candidate Screening

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

83 daysmedian FDA review time
495 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942439ZEISS OPMILAS 144 SURGICAL LASERSZeiss Humphrey System1994-07-011120
K923211DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPEZeiss Humphrey System1993-11-084950
K923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIEDZeiss Humphrey System1992-12-101960
K852639HUMPHREY FIELD ANALYZER MODEL 630Zeiss Humphrey System1985-09-18900
K852638HUMPHREY IMAGE ANALYZER MODEL 110Zeiss Humphrey System1985-08-12530
K821940THE HUMPHREY FIELD ANALYZER MODEL 610Zeiss Humphrey System1982-07-28290
K802029OBJECTIVE REFRACTORZeiss Humphrey System1980-11-12830
K781994AUTOKERATOMETER, INSTRUMENTZeiss Humphrey System1979-02-12750
K782096INSTRUMENTS, OVERREFRACTION SYSTEMZeiss Humphrey System1979-01-26390

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