Cooper Medical Devices Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cooper Medical Devices Corp.” (first 1979, latest 1981), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| HJI | Lens, Fundus, Hruby, Diagnostic | 2 | 2 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cooper Medical Devices Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802971 | LANDERS CONTACT LENS | HJI | 1981-02-05 | 76 |
| K802927 | SEBESTYEN IRRIGATING CONTACT LENS | HJI | 1981-02-05 | 78 |
| K801850 | CHARLES PNEUMATIC INTRAOCULAR SCISSORS | HQE | 1980-09-16 | 43 |
| K801411 | MAY ILLUMINATED/INFUSION PIC | HMX | 1980-07-21 | 35 |
| K801312 | THE PROTECTORS | — | 1980-06-17 | 14 |
| K800833 | VABRA ASPIRATOR | HHI | 1980-05-14 | 30 |
| K791898 | OCUTOME MODEL 8000 | HKP | 1979-10-30 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Cooper Medical Devices 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.
- Cooper Lasersonics, Inc. (54 510(k)s)
- Cooper Biomedical, Inc. (19 510(k)s)
- Cooper-Hewitt Electric Co. (8 510(k)s)
- Cooper Surgical (6 510(k)s)
- Cooper Medical Corp. (5 510(k)s)
- Cooper Diagnostics, Inc. (1 510(k)s)
- Cooper Laboratories (1 510(k)s)
- Cooper Surgical/Aesthete (1 510(k)s)
- The Cooper Companies (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper Medical Devices Corp.?
FDA lists 7 510(k) clearances under the applicant name “Cooper Medical Devices Corp.” (first 1979, latest 1981), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cooper Medical Devices Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper Medical Devices Corp. is 35 days.
Which FDA product codes appear under Cooper Medical Devices Corp.?
The most frequent FDA product codes under this applicant name are HJI (Lens, Fundus, Hruby, Diagnostic, 2); HHI (System, Abortion, Vacuum, 1); HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered, 1).
Next steps
- See all 7 Cooper Medical Devices Corp. clearances with predicates and recalls
- Run predicate analysis for product code HJI, Cooper Medical Devices 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.