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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972440 | CATARACTSCREENER CT - S | Neitz Instruments Company, Ltd. | 1997-09-30 | 92 | 0 |
| K951341 | NEITZ SLIT LAMP SL-H2 | Neitz Instruments Company, Ltd. | 1995-06-15 | 83 | 0 |
| K951337 | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | 1995-06-08 | 76 | 0 |
| K950788 | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | 1995-05-03 | 71 | 0 |
| K951340 | NEITZ SLIT LAMP SL-H1 | Neitz Instruments Company, Ltd. | 1995-04-10 | 17 | 0 |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Neitz Instruments Company, Ltd. | 1995-04-07 | 14 | 0 |
| K950791 | STREAK RETINOSCOPE RX-3 | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950795 | STREAK RETINOSCOPE RX-RP | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950793 | SPOT RETINOSCOPE RX-3SP | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950794 | STREAK RETINOSCOPE RX-RC | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950792 | STREAK RETINOSCOPE RX-3A | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950790 | STREAK RETINOSCOPE RX-2 | Neitz Instruments Company, Ltd. | 1995-03-22 | 29 | 0 |
| K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 | Neitz Instruments Company, Ltd. | 1995-03-22 | 29 | 0 |
| K942719 | NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
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