Exelint Intl. Co.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Exelint Intl. Co.” (first 2000, latest 2010), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 154 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 | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
Review panels
Most recent Exelint Intl. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092172 | EXEL I.V. EXTENSION SET | FPA | 2010-01-04 | 167 |
| K052103 | EXEL SECURE TOUCH II SAFETY SYRINGE | MEG | 2005-10-19 | 77 |
| K031500 | EXCEL PRIMARY SOLUTION SET | FPA | 2003-07-25 | 73 |
| K011754 | EXEL SECURETOUCH PTP SYRINGE | MEG | 2003-01-22 | 595 |
| K020533 | EXEL VACULET BLOOD COLLECTION SET | FPA | 2002-12-02 | 286 |
| K022406 | EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET | FMI | 2002-09-30 | 69 |
| K011757 | EXEL COMFORTPOINT INSULIN PEN NEEDLE | FMI | 2002-01-23 | 231 |
| K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE | FPA | 2002-01-17 | 142 |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | FIE | 2001-12-07 | 88 |
| K011405 | EXEL INJECTION PLUG WITH CAP | FPA | 2001-09-27 | 142 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Exelint Intl. Co..
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.
- Exelint International, Co. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Exelint Intl. Co.?
FDA lists 12 510(k) clearances under the applicant name “Exelint Intl. Co.” (first 2000, latest 2010), across 5 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 Exelint Intl. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exelint Intl. Co. is 154 days.
Which FDA product codes appear under Exelint Intl. Co.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 6); FMI (Needle, Hypodermic, Single Lumen, 2); MEG (Syringe, Antistick, 2).
Next steps
- See all 12 Exelint Intl. Co. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Exelint Intl. Co.'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.