Gerard Medical Enterprises, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Gerard Medical Enterprises, Inc.” (first 1981, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 139 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 5 | 5 |
| FMF | Syringe, Piston | 2 | 2 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 1 | 1 |
Review panels
- General Hospital (7)
- Cardiovascular (1)
Most recent Gerard Medical Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | LJT | 1996-05-24 | 262 |
| K945250 | TRIMPORT | LJT | 1995-03-07 | 130 |
| K942623 | TRIMPORT | LJT | 1994-08-23 | 88 |
| K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM | LJT | 1992-12-04 | 211 |
| K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT | FMF | 1992-01-02 | 178 |
| K912111 | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE | FMF | 1991-10-08 | 148 |
| K903364 | GERARD MEDICAL, INC. TRIM-PORT | LJT | 1990-10-31 | 97 |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | KRC | 1981-12-29 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Gerard Medical Enterprises, 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.
- Gerard Medical, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gerard Medical Enterprises, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Gerard Medical Enterprises, Inc.” (first 1981, latest 1996), across 3 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 Gerard Medical Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gerard Medical Enterprises, Inc. is 139 days.
Which FDA product codes appear under Gerard Medical Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 5); FMF (Syringe, Piston, 2); KRC (Tester, Electrode, Surface, Electrocardiographic, 1).
Next steps
- See all 8 Gerard Medical Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Gerard Medical Enterprises, 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.