Dutch Ophthalmic USA, Inc.: FDA clearances and approvals
Dutch Ophthalmic USA, Inc. has 10 FDA 510(k) clearances (first 1990, latest 2001), across 8 product codes in 2 review panels. Median 510(k) review time: 88 days. openFDA lists 3 product recalls by a recalling firm named Dutch Ophthalmic USA, Inc.
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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| MPA | Endoilluminator | 2 | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| HPS | Unit, Cryophthalmic | 1 | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
| HRN | Unit, Cryophthalmic, Ac-Powered | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 1 | 1 |
Review panels
Most recent Dutch Ophthalmic USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | HRN | 2001-10-22 | 60 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | HQE | 2001-03-12 | 61 |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | HQE | 1999-03-03 | 126 |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | FFS | 1998-05-20 | 90 |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | MPA | 1997-11-25 | 90 |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | MPA | 1997-11-07 | 36 |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | HQO | 1996-08-29 | 87 |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | KYG | 1996-04-15 | 175 |
| K940373 | OPHTHALMIC CRYO UNIT | HPS | 1994-07-18 | 173 |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | MLP | 1990-06-26 | 21 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-04-14.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Dutch Ophthalmic USA, Inc.'s product codes (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MLP)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MLP)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MLP)
Frequently asked questions
How many FDA 510(k) clearances does Dutch Ophthalmic USA, Inc. have?
Dutch Ophthalmic USA, Inc. has 10 FDA 510(k) clearances (first 1990, latest 2001), across 8 product codes in 2 review panels.
How long does FDA take to clear Dutch Ophthalmic USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dutch Ophthalmic USA, Inc.'s cleared 510(k)s is 88 days.
What devices does Dutch Ophthalmic USA, Inc. make?
Its most frequent FDA product codes are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2); MPA (Endoilluminator, 2); FFS (Image, Illumination, Fiberoptic, For Endoscope, 1).
Has Dutch Ophthalmic USA, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Dutch Ophthalmic USA, Inc; the most recent began 2021-04-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Dutch Ophthalmic USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, Dutch Ophthalmic USA, Inc.'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.