Exel Intl.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Exel Intl.” (first 1986, latest 2000), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 143 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 6 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| DZM | Needle, Dental | 1 | 1 |
| FDZ | Attachment, Eyepiece, For Insertion Of Prescription Lens | 1 | 1 |
| FIE | Needle, Fistula | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 | 1 |
Review panels
- General Hospital (13)
- Gastroenterology and Urology (2)
- Clinical Chemistry (1)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Exel Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992290 | EXEL INJECTION PLUG WITH CAP | FPA | 2000-02-23 | 231 |
| K963658 | EXEL AVF SINGLE NEEDLE | FMI | 1998-05-05 | 609 |
| K963659 | EXEL I.V. ADMINISTRATION SET | FPA | 1997-12-16 | 469 |
| K926119 | EXEL HUBER INFUSION SET ROTATING WING | FPA | 1993-08-11 | 251 |
| K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) | FPA | 1990-11-21 | 48 |
| K903945 | EXEL A-V FISTULA SET | FIE | 1990-11-20 | 85 |
| K895770 | EXEL HUBER INFUSION SET | FPA | 1990-07-19 | 296 |
| K895772 | EXEL INDWELLING CATHETER | FDZ | 1990-02-16 | 143 |
| K895771 | EXEL SPINAL NEEDLES | FMI | 1990-02-16 | 143 |
| K895769 | EXEL HUBER NEEDLE | FMI | 1990-02-16 | 143 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Exel Intl..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Exel Intl.?
FDA lists 18 510(k) clearances under the applicant name “Exel Intl.” (first 1986, latest 2000), across 10 product codes in 5 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 Exel Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exel Intl. is 143 days.
Which FDA product codes appear under Exel Intl.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 6); FMI (Needle, Hypodermic, Single Lumen, 4); DZM (Needle, Dental, 1).
Next steps
- See all 18 Exel Intl. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Exel Intl.'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.