Copioumed Intl., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Copioumed Intl., Inc.” (first 1996, latest 2003), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 128 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 4 | 4 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Copioumed Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030927 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | 2003-04-17 | 24 |
| K021961 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | LYZ | 2002-07-02 | 18 |
| K021743 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW | LZA | 2002-06-10 | 13 |
| K972624 | POLY (VINYL) EXAM GLOVE, POWDER-FREE | LYZ | 1997-11-06 | 115 |
| K971316 | POLY (VINYL) EXAM GLOVE, POWDERED | LYZ | 1997-08-27 | 140 |
| K965237 | NURSES BOUFFANT CAP | LYU | 1997-08-27 | 239 |
| K961342 | SHOE COVER, NON-STERILE | FXP | 1996-12-30 | 285 |
| K960999 | ISOLATION GOWN | FYC | 1996-12-30 | 293 |
Recalls
openFDA lists no recalls under a recalling firm named Copioumed Intl., Inc..
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.
- Copioumed International, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Copioumed Intl., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Copioumed Intl., Inc.” (first 1996, latest 2003), across 5 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 Copioumed Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Copioumed Intl., Inc. is 128 days.
Which FDA product codes appear under Copioumed Intl., Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 4); FXP (Cover, Shoe, Operating-Room, 1); FYC (Gown, Isolation, Surgical, 1).
Next steps
- See all 8 Copioumed Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Copioumed Intl., Inc.'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.