Intl. Ophthalmic Industries Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Intl. Ophthalmic Industries Corp.” (first 1979, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 4 | 4 |
| HJM | Transilluminator, Ac-Powered | 1 | 1 |
| HRG | Engine, Trephine, Accessories, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Intl. Ophthalmic Industries Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | HQC | 1996-07-23 | 85 |
| K894513 | DIATHRON(R) DIATHERMY UNIT | HJM | 1989-10-31 | 104 |
| K894512 | PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS | HQC | 1989-10-17 | 90 |
| K894511 | MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT | HQC | 1989-10-17 | 90 |
| K823088 | ASPITRON | HQC | 1983-04-06 | 169 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | HRG | 1979-11-05 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. Ophthalmic Industries Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Ophthalmic Industries Corp.?
FDA lists 6 510(k) clearances under the applicant name “Intl. Ophthalmic Industries Corp.” (first 1979, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intl. Ophthalmic Industries Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Ophthalmic Industries Corp. is 90 days.
Which FDA product codes appear under Intl. Ophthalmic Industries Corp.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 4); HJM (Transilluminator, Ac-Powered, 1); HRG (Engine, Trephine, Accessories, Ac-Powered, 1).
Next steps
- See all 6 Intl. Ophthalmic Industries Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Intl. Ophthalmic Industries Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.