Gainor Medical: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Gainor Medical” (first 1984, latest 1987), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 165 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 4 | 4 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| GKX | Instrument, Automated Platelet Counting | 1 | 1 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 1 | 1 |
Review panels
Most recent Gainor Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850100 | BLOOD LANCET | FMK | 1987-01-29 | 748 |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | FMK | 1985-02-21 | 38 |
| K844306 | GAINOR MEDICAL SYRINGE | FMF | 1984-11-30 | 24 |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | FMI | 1984-11-30 | 24 |
| K840951 | FIRST AID BANDAGE | KGX | 1984-10-31 | 240 |
| K840950 | ZINC OXIDE TAPE | KGX | 1984-10-31 | 240 |
| K840945 | SKIN CLOSURE | FPX | 1984-10-31 | 240 |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | KGX | 1984-08-17 | 165 |
| K840947 | CLOTH-HYPOALLERGENIC | KGX | 1984-08-17 | 165 |
| K840946 | MICROPOROUS HYPOALLERGENIC | KGW | 1984-08-17 | 165 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gainor Medical.
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 Europe, Ltd. (13 510(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?
FDA lists 11 510(k) clearances under the applicant name “Gainor Medical” (first 1984, latest 1987), across 7 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gainor Medical is 165 days.
Which FDA product codes appear under Gainor Medical?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 4); FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 2); FMF (Syringe, Piston, 1).
Next steps
- See all 11 Gainor Medical clearances with predicates and recalls
- Run predicate analysis for product code KGX, Gainor Medical'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.