Gainor Medical Europe, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Gainor Medical Europe, Ltd.” (first 1990, latest 1994), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 173 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| FIE | Needle, Fistula | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
- Gastroenterology and Urology (5)
- General and Plastic Surgery (4)
- General Hospital (3)
- Anesthesiology (1)
Most recent Gainor Medical Europe, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | FPA | 1994-05-02 | 495 |
| K931828 | CARELET SAFETY LANCET | FMK | 1993-10-15 | 190 |
| K931827 | CLEANLET, CLEANLET XL & KIDS | FMK | 1993-09-13 | 158 |
| K922441 | SURESEAL BANDAGE | KGX | 1993-08-10 | 445 |
| K913333 | I.V. PRIMING SET | FPA | 1991-10-23 | 89 |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | FMI | 1991-06-06 | 371 |
| K902420 | CATHETER, NASAL, OXYGEN | CAT | 1991-04-17 | 321 |
| K902564 | NEEDLE, DIALYSIS | FIE | 1991-03-01 | 263 |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | FJK | 1990-11-20 | 173 |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | KDH | 1990-11-20 | 173 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gainor Medical Europe, Ltd..
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.
- Gainor Medical (11 510(k)s)
- Gainor Medical U.S.A., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gainor Medical Europe, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Gainor Medical Europe, Ltd.” (first 1990, latest 1994), across 10 product codes in 4 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 Gainor Medical Europe, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gainor Medical Europe, Ltd. is 173 days.
Which FDA product codes appear under Gainor Medical Europe, Ltd.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 3); FPA (Set, Administration, Intravascular, 2); CAT (Cannula, Nasal, Oxygen, 1).
Next steps
- See all 13 Gainor Medical Europe, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Gainor Medical Europe, Ltd.'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.