Mediflex Intl.: FDA clearances and approvals
Mediflex Intl. has 9 FDA 510(k) clearances (first 1984, latest 1992), across 7 product codes in 3 review panels. Median 510(k) review time: 55 days.
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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| GCE | Adaptor, Catheter | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Mediflex Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915140 | PRIMARY DRESSING TRAY | LYY | 1992-02-11 | 90 |
| K900841 | HEMODIALYSIS TRANSDUCER PROTECTOR | FIB | 1990-05-15 | 82 |
| K891077 | MEDIVERSE PARENTERAL NUTRITION BAG | KPE | 1989-05-24 | 84 |
| K884243 | BLOOD TUBING SET | FJK | 1988-12-08 | 58 |
| K863496 | MEDIFLEX TRANSDUCER PROTECTOR | FIB | 1986-09-23 | 14 |
| K855039 | MEDIFLEX INJECTION CAP | GCE | 1986-01-24 | 38 |
| K854346 | MEDIFLEX DISPOSABLE TUBING CLAMP | FPA | 1985-11-18 | 20 |
| K852106 | I.V. ADMINISTRATION SET | FPA | 1985-06-07 | 23 |
| K843126 | MEDIFLEX DRAINAGE BAG | KNX | 1984-10-04 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Mediflex Intl..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Mediflex Intl. have?
Mediflex Intl. has 9 FDA 510(k) clearances (first 1984, latest 1992), across 7 product codes in 3 review panels.
How long does FDA take to clear Mediflex Intl.'s 510(k)s?
The median time from FDA receipt to decision across Mediflex Intl.'s cleared 510(k)s is 55 days.
What devices does Mediflex Intl. make?
Its most frequent FDA product codes are FIB (Protector, Transducer, Dialysis, 2); FPA (Set, Administration, Intravascular, 2); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 1).
Has Mediflex Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mediflex Intl. Related entities may recall under other names.
Next steps
- See all 9 Mediflex Intl. clearances with predicates and recalls
- Run predicate analysis for product code FIB, Mediflex Intl.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.