Exelint International, Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Exelint International, Co.” (first 2000, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 | 1 | 89 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 246 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Exelint International, Co. took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 179 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
Most recent Exelint International, Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | FMF | 2025-12-12 | 246 |
| K152183 | EXELINT SecureTouch Safety Hypodermic Needle | FMI | 2015-11-02 | 89 |
| K101309 | EXELINT ALUMINUM HUB BLUNT NEEDLES | LHI | 2010-10-20 | 163 |
| K020189 | EXEL BUTTERFLY SCALP VEIN SET | FPA | 2003-03-27 | 433 |
| K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET | FPA | 2001-05-14 | 112 |
| K003627 | EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET | FMI | 2001-02-08 | 76 |
| K001496 | A.V. FISTULA NEEDLE | FIE | 2000-08-01 | 78 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-12-23.
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 Intl. Co. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Exelint International, Co.?
FDA lists 7 510(k) clearances under the applicant name “Exelint International, Co.” (first 2000, latest 2025), 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 International, Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exelint International, Co. is 112 days.
Which FDA product codes appear under Exelint International, Co.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); FPA (Set, Administration, Intravascular, 2); FIE (Needle, Fistula, 1).
Next steps
- See all 7 Exelint International, Co. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Exelint International, 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.