Atlas FDA

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

Neitz Instruments Company, Ltd. — Predicate Candidate Screening

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

57 daysmedian FDA review time
76 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972440CATARACTSCREENER CT - SNeitz Instruments Company, Ltd.1997-09-30920
K951341NEITZ SLIT LAMP SL-H2Neitz Instruments Company, Ltd.1995-06-15830
K951337FIBER HEAD LIGHT FH-300Neitz Instruments Company, Ltd.1995-06-08760
K950788OTOSCOPE A-34Neitz Instruments Company, Ltd.1995-05-03710
K951340NEITZ SLIT LAMP SL-H1Neitz Instruments Company, Ltd.1995-04-10170
K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TVNeitz Instruments Company, Ltd.1995-04-07140
K950791STREAK RETINOSCOPE RX-3Neitz Instruments Company, Ltd.1995-03-28350
K950795STREAK RETINOSCOPE RX-RPNeitz Instruments Company, Ltd.1995-03-28350
K950793SPOT RETINOSCOPE RX-3SPNeitz Instruments Company, Ltd.1995-03-28350
K950794STREAK RETINOSCOPE RX-RCNeitz Instruments Company, Ltd.1995-03-28350
K950789STREAK RETINOSCOPE RX-1Neitz Instruments Company, Ltd.1995-03-28350
K950797HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134Neitz Instruments Company, Ltd.1995-03-28350
K950792STREAK RETINOSCOPE RX-3ANeitz Instruments Company, Ltd.1995-03-28350
K950790STREAK RETINOSCOPE RX-2Neitz Instruments Company, Ltd.1995-03-22290
K950796HALOGEN DIAGNOSTIC SET BX A - 12345Neitz Instruments Company, Ltd.1995-03-22290
K942719NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JRNeitz Instruments Company, Ltd.1994-08-05570
K942715NEITZ HALOGEN OPHTHALMOSCOPE BXA-RCNeitz Instruments Company, Ltd.1994-08-05570
K942713NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-HNeitz Instruments Company, Ltd.1994-08-05570
K942712NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-ANeitz Instruments Company, Ltd.1994-08-05570
K942714NEITZ HALOGEN OPHTHALMOSCOPE BXA-RPNeitz Instruments Company, Ltd.1994-08-05570
K942711NEITZ HALOGEN OPHTHALMOSCOPE BXA-123Neitz Instruments Company, Ltd.1994-08-05570
K942721NEITZ HALOGEN OPHTHALMOSCOPE BXA-13Neitz Instruments Company, Ltd.1994-08-05570
K942717NEITZ HALOGEN OPHTHALMOSCOPE BXA-13ANeitz Instruments Company, Ltd.1994-08-05570
K942720NEITZ HALOGEN OPHTHALMOSCOPE BXA-12Neitz Instruments Company, Ltd.1994-08-05570

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