Neitz Instruments Company, Ltd.: FDA clearances and approvals
Neitz Instruments Company, Ltd. has 24 FDA 510(k) clearances (first 1994, latest 1997), across 8 product codes in 2 review panels. Median 510(k) review time: 57 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 7 | 7 |
| HKM | Retinoscope, Battery-Powered | 5 | 5 |
| HLJ | Ophthalmoscope, Battery-Powered | 5 | 5 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| HKL | Retinoscope, Ac-Powered | 2 | 2 |
| ERA | Otoscope | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HPQ | Headlamp, Operating, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (23)
- Ear, Nose and Throat (1)
Most recent Neitz Instruments Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972440 | CATARACTSCREENER CT - S | HKI | 1997-09-30 | 92 |
| K951341 | NEITZ SLIT LAMP SL-H2 | HJO | 1995-06-15 | 83 |
| K951337 | FIBER HEAD LIGHT FH-300 | HPQ | 1995-06-08 | 76 |
| K950788 | OTOSCOPE A-34 | ERA | 1995-05-03 | 71 |
| K951340 | NEITZ SLIT LAMP SL-H1 | HJO | 1995-04-10 | 17 |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | HLI | 1995-04-07 | 14 |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | HLJ | 1995-03-28 | 35 |
| K950795 | STREAK RETINOSCOPE RX-RP | HKM | 1995-03-28 | 35 |
| K950794 | STREAK RETINOSCOPE RX-RC | HKM | 1995-03-28 | 35 |
| K950793 | SPOT RETINOSCOPE RX-3SP | HKM | 1995-03-28 | 35 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neitz Instruments Company, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neitz Instruments Company, Ltd. have?
Neitz Instruments Company, Ltd. has 24 FDA 510(k) clearances (first 1994, latest 1997), across 8 product codes in 2 review panels.
How long does FDA take to clear Neitz Instruments Company, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Neitz Instruments Company, Ltd.'s cleared 510(k)s is 57 days.
What devices does Neitz Instruments Company, Ltd. make?
Its most frequent FDA product codes are HLI (Ophthalmoscope, Ac-Powered, 7); HKM (Retinoscope, Battery-Powered, 5); HLJ (Ophthalmoscope, Battery-Powered, 5).
Has Neitz Instruments Company, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neitz Instruments Company, Ltd. Related entities may recall under other names.
Next steps
- See all 24 Neitz Instruments Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HLI, Neitz Instruments Company, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.